Prevention Programme - Vaccines (Eurovac)

Lead Research Organisation: MRC Clinical Trials Unit

Abstract

This large project brings together several experts in Europe in the HIV vaccine field. The efforts are concentrated on identifying candidate vaccines based on the C sub-type which circulates in Africa and China, and manufacturing them to high standards. They will then be tested for safety in clinical trials in healthy volunteers at low risk of HIV infection. Volunteers will be recruited from two centres: St Marys Hospital, London, UK and Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, for the third trial extra centres have been added, Universitats Klinikum, Regensburg, Germany and six sites in France (co-ordinated by ANRS) The immune responses will be measured by testing (in the laboratory) the reactions of blood cells collected from volunteers. It is hoped that the candidate products will be safe and will evoke immune responses sufficiently encouraging to proceed to larger clinical trials. This third trial has completed recruitment and is now in followup.||A second part of the assessment of the candidates will be to monitor the immune responses to each product.

Technical Summary

The aim of this programme was the development and early assessment of several novel HIV vaccine constructs. It is hoped that at least one immunogen will elicit a sufficiently broad and durable immune response to justify proceeding to a larger safety (Phase II) trial. The principal scientific objectives were: 1) to manufacture to Good Manufacturing Practice (GMP) standards 3 different constructs based on recombinant vaccinia vectors: MVA and NYVAC each containing a HIV clade B insert, and a NYVAC with a HIV clade C insert. DONE 2) to manufacture to GMP a DNA construct with a clade C insert. DONE 3) to manufacture to GMP a Semliki Forest Virus (SFV) vector with a clade C insert. FAILED DUE TO SCALE-UP DIFFICULTIES. 4) to manufacture to GMP a recombinant protein based on clade C envelope. DONE. 5) to assess the safety of these products in a series of clinical trials. EV01;NYVAC, EVO2; DNA/NYVAC vs NYVAC ALONE, EV03/ANRSvac20: 3DNA/1NYVAC vs 2DNA/2NYVAC 6) to compare the immunogenicity of the two vaccinia vectors in terms of ELISPOT responses to pools of gag peptides. FAILED DUE TO TIME CONSTRAINTS OF THE GRANT. 7) to compare the cellular immunogenicity of the clade C constructs (NYVAC, DNA, SFV). DNA NYVAC COMPARED TO NYVAC ALONE IN EV02. 8) to explore the cellular immunogenicity of combination regimens with these constructs SEE 7) ABOVE. 9) to explore the humoral immunogenicity of these constructs in regimens containing a recombinant protein boost. FAILED DUE TO TIME CONSTRAINTS OF THE GRANT. 10) to conduct parallel challenge experiments in animal models. DONE. The plan of the investigation The initial work will focus on producing the constructs to GMP. Once products become available they will undergo the necessary pre-clinical tests to underscore sterility, stability and lack of contaminant material as well as the repeated dose toxicity experiments required to support a Phase I clinical trial. The trials will be conducted in two clinical centres: St Marys Hospital, London UK and Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. CTU will coordinate the development of the protocol, case record forms, database, monitoring and oversight (Trial Steering Committee and Data and Safety Monitoring Committee meetings).For Eurovac III (phaseI/II) an additional clinical centre was added: Universitats Klinikum, Regensburg, Germany plus under ANRS co-ordination 6 sites in France. The ELISPOT and intracellular cytokine assays will be conducted in Lausanne. Parallel challenge studies will be conducted in Holland.

Organisations

Publications

10 25 50

 
Description CMO Seminar on future public health policy for HIV research
Geographic Reach National 
Policy Influence Type Participation in advisory committee
Impact As a result of the seminar the CMO wrote to all GPs advising them to test patients presenting with glandular fever symptoms for HIV. The legalisation of self-testing was also raised and subsequently the CMO announced that the law would be changed from April 2014.
 
Description Consultation on Standards of Care in HIV prevention trials
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact Followed on from review of standards of care and prevention which MDP participated in. Presentation available to other practitioners. Report of meeting.
 
Description Consultation on Standards of Care in HIV prevention trials
Geographic Reach Africa 
Policy Influence Type Participation in a advisory committee
 
Description Dr. Sarah Joseph attendance at meeting: Vaccine-Induced Sero-Positivity/Sero-Reactivity (VISP/SR) meeting, Bethesda, USA 14-15 March 2013
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in advisory committee
Impact Health providers made aware of the impact of HIV vaccines on HIV test results with an increase in the risk of vaccine associated positive results
URL http://www.vaccineenterprise.org/content/timely-topic-VISP
 
Description Entry in the EDCTP Annual Report 2013 (published June 2014)
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact The MDP301 project which EDCTP co-funded was chosen as an example of good practice. EDCTP funding allowed microbicides to be introduced into Mozambique for the first time, with training of clinicians and researchers largely undertaken by the team from the University of Witswatersrand in Johannesburg.
URL http://www.edctp.org/annualreport2013
 
Description Europrise Steering Committee
Geographic Reach Europe 
Policy Influence Type Participation in advisory committee
 
Description Good Participatory Practice Guideline
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in other policy documents
Impact The methods we developed for community engagement made use of participatory methodology. This has not previously been used in HIV prevention trials to our knowledge. It provided a mechanism for feedback that led to improvement in recruitment, retention and adherence, but most importantly ensured that the trial was conducted to the highest ethical standards in consultation with the community.
 
Description Good Participatory Practice Guidelines: case studies
Geographic Reach Africa 
Policy Influence Type Influenced training of practitioners or researchers
Impact Shared to research staff as lessons to improve implementation of GPP
URL http://www.avac.org/implementation-tools
 
Description House of Lords Select Committee chaired by Lord Fowler
Geographic Reach Multiple continents/international 
Policy Influence Type Gave evidence to a government review
Impact Following this consultation home testing for HIV was became legal (April 2014)
 
Description WHO/UNAIDS ethical conduct of HIV prevention trials guidelines
Geographic Reach Multiple continents/international 
Policy Influence Type Membership of a guidance committee
Impact Published UNAIDS 2008
 
Description WHO/UNAIDS ethical conduct of HIV prevention trials guidelines
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in advisory committee
Impact The updated guidelines have been disseminated to research groups internationally and have influenced the dialogue between researchers and communities, facilitating joint ownership of large research projects even in resource limited settings.
 
Description CUTHIVAC (European Commission Collaborative Project - Large Scale Integrating Project)
Amount £324,810 (GBP)
Funding ID 241904 
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 01/2010 
End 12/2015
 
Description Clinical Trial/Capacity Building - Tamovac II
Amount £450,651 (GBP)
Funding ID IP.07.33112.001 
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start 11/2009 
End 11/2014
 
Description Clinical Trial/capacity building - Afrevac
Amount £193,790 (GBP)
Funding ID CT.2006.33111.001 
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start 03/2008 
End 03/2012
 
Description Clinical trial Collaboration - UKHVC
Amount £491,380 (GBP)
Funding ID 083844 
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 04/2008 
End 03/2016
 
Description EDCTP2 (RIA2016V - Vaccines for povery related diseases): 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' (PrEPVacc)
Amount € 14,999,954 (EUR)
Funding ID RIA2016V - 1644 
Organisation Sixth Framework Programme (FP6) 
Department European and Developing Countries Clinical Trials Partnership
Sector Public
Country European Union (EU)
Start 01/2018 
End 12/2022
 
Description European Commission H2020-PHC-2015-single-stage_RTD (PHC-09-2015) 'European HIV Vaccine Alliance - EHVA)
Amount € 22,188,522 (EUR)
Funding ID 681032 (RIA - Research and Innovation Action) 
Organisation National Institute of Health and Medical Research (INSERM) 
Sector Public
Country France
Start 01/2016 
End 12/2020
 
Description Network of Excellence
Amount £134,664 (GBP)
Funding ID 037611 
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 01/2007 
End 12/2011
 
Description TRANSVAC
Amount € 1 (EUR)
Funding ID TNA1204-5 - HIV_vaccine_breakthrough 
Organisation European Commission 
Department Seventh Framework Programme (FP7)
Sector Public
Country European Union (EU)
Start 07/2012 
End 09/2013
 
Description UKHIV Vaccine Consortium spoke 003 trial: MRC DCS scheme
Amount £66,415 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 07/2012 
End 07/2014
 
Title EV02 Clinical Study Report 
Description Final Clinical Study Report of the EV02 trial of DNA/NYVAC compared to DNA 
Type Of Material Improvements to research infrastructure 
Year Produced 2008 
Provided To Others? Yes  
Impact Established the value of DNA priming 
 
Title EV02 protocol and case record forms 
Description Protocol and case record forms to support a Phase I trial of a candidate HIV vaccine regimen comparing DNA prime and NYVAC boost to NYVAC alone. 
Type Of Material Improvements to research infrastructure 
Year Produced 2006 
Provided To Others? Yes  
Impact Provided to the HIVIS group which enabled them to implement their own DNA/MVA trial in Sweden and later in participants in Tanzania in collaboration with MUHAS 
 
Title EV03 Clinical Study Report 
Description Report of Phase IIa trial of 3xDNA/1xNYVAC compared to 2xDNA/2xNYVAC that demonstrated benefit of third DNA prime. 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact Trials continue with 3xDNA priming 
 
Title MucoVac2 Clinical Study Report 
Description The contents of a Clinical Study Report are defined in the International Conference on Harmonisation of technical reports E3 guideline. The report summarises the rationale, design, safety and efficacy data collected, data and trial management structures, as well as the primary and secondary analyses and a line listing of all adverse events that occured during the trial. 
Type Of Material Improvements to research infrastructure 
Year Produced 2014 
Provided To Others? Yes  
Impact Providing the report has helped other groups to draft their reports. 
 
Title Pre-Exposure Prophylaxis (PrEP) Trial Designs in Europe meeting, Windsor, 4-5/07/16 
Description This meeting brought together European clinicians with experience of PrEP trials and demonstration studies and those without. Data collection tools were shared and a uniform approach to PrEP monitoring agreed. From the presentations it was clear from 2015 data that there is an ongoing HIV epidemic in Europe amongst key populations, and that there is capacity to conduct clinical trials. Importantly the regulators present expressed their willingness to review alternative trial designs for pivotal trials. 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact A large PrEP trial is now underway in several European countries, and data collection tools are harmonised. Capacity for review and conduct of PrEP trials has been built. 
 
Title Protocol for the CUTHIVAC preventative trial CUTHIVAC_001 
Description The protocol which had been developed for a Phase I clinical trial running in London has been shared with another team within the CUTHIVAC consortium who are planning a trial using the same routes of vaccination in Peru. 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact The protocol relates to a clinical trial in healthy humans. 
 
Title Quantitative assay for the measurement of binding antibodies against CN54rgp140 
Description Technology transfer between Imperial College and collaborating institutions within Tanzania (MUHAS, MMRC). Training was carried out involving members of the Imperial and MRC teams. 
Type Of Material Technology assay or reagent 
Provided To Others? No  
Impact The assay will allow the quantitative assessment of an important endpoint in several trials using common reagents and so direct comparison of results across trials which would be extremely valuable. 
 
Title CUTHIVTHER study database 
Description Therapeutic vaccine trial database. 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact Generation of reports for safety monitoring by the Trial Management Group and Independent Data Monitoring Committee 
 
Title Cuthivac 002 study database 
Description HIV vaccine trial database 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact Generation of reports for safety monitoring by the Trial Management Group and Independent Data Monitoring Committee 
 
Title EHVA-T01 trial database 
Description Database developed and released for EHVA-T01 trial 
Type Of Material Database/Collection of data 
Year Produced 2018 
Provided To Others? No  
Impact No impact yet. Database being populated as trial accrues. 
 
Title MucoVac 2 study database 
Description This was one of the first study databases created using our in-house software CACTUS. 
Type Of Material Database/Collection of data 
Provided To Others? No  
Impact CACTUS was developed in order to have control over development and change without dependencies on external contractors, and with resource limited settings in mind. The existence of the programmes that support the vaccine trial database will streamline implementation of vaccine trials in future. 
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Eurovacc Foundation
Country Switzerland 
Sector Charity/Non Profit 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Gilead Sciences, Inc.
Country United States 
Sector Private 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Imperial College London
Country United Kingdom 
Sector Academic/University 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation International AIDS Vaccine Initiative (IAVI)
Country Global 
Sector Charity/Non Profit 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Karolinska Institute
Country Sweden 
Sector Academic/University 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Lausanne University Hospital (CHUV)
Country Switzerland 
Sector Hospitals 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Ludwig Maximilian University of Munich (LMU Munich)
Country Germany 
Sector Academic/University 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Medical Research Council of South Africa (MRC)
Country South Africa 
Sector Public 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Muhimbili University of Health and Allied Sciences
Country Tanzania, United Republic of 
Sector Academic/University 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation National Institute for Medical Research, Tanzania
Country Tanzania, United Republic of 
Sector Public 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation National Institute of Health, Mozambique
Country Mozambique 
Sector Public 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation Uganda National Health Research Organisation
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis (PrEPVacc) 
Organisation University of KwaZulu-Natal
Department KwaZulu-Natal Research Institute for Tuberculosis and HIV (K-RITH)
Country South Africa 
Sector Charity/Non Profit 
PI Contribution We are responsible for the innovative trial design and the Independent Data Monitoring Committee. We will provide mentorship to MRC/UVRI at LSHTM as they are coordinating an international trial for the first time, and practical support including our unit templates and procedures. We will work closely with IAVI to develop a risk based monitoring plan.
Collaborator Contribution Imperial College will sponsor the trial and oversee the provision of vaccine products supported by the EuroVacc Foundation and CHUV. Gilead Sciences will provide the PrEP. The trial and preceding registration cohort will be conducted at MRC SA in Durban, MUHAS in Dar supported by KI, NIMR MMRC in Mbeya supported by LMU, INS in Maptuo and MRC/UVRI in Masaka. IAVI will carry out the on site monitoring.
Impact Registration cohort up and running in all 5 centres. Site Assessments conducted in 2 centres..
Start Year 2018
 
Description AfreVacc I 
Organisation Imperial College London
Department Imperial Clinical Trials Unit (ICTU)
Country United Kingdom 
Sector Academic/University 
PI Contribution Significant intellectual input into the establishment of a new network devoted to HIV vaccine development in the South harnessing the best methodologies and using constructs developed and taken to Phase I/II trials in Europe by the EuroVacc foundation, Significant intellectual input into builiding vaccine trial capacity in South Africa, Tanzania and Mozambique initially by purusing feasibility studies in at risk populations, sharing of exisiting data and expertise in the drafting of protocols and relevant documentation, contributions to design of clinical trials and studies, provision of appropriate training in all aspects of trial design and management, overall responsibility for the management of the trial and drafting of relevant documentation
Collaborator Contribution Logistical and project management, Co-ordination of monthly calls, Planning and organisation of annual investigator meetings, Collation of 6 monthly and annual reports. Co-ordination of training, Integration of other networks, submission of applications for no cost extension
Impact Protocols approved for feasibility studies in South Africa, Mozambique and Tanzania. Contribution to creation of free access on line database for centralised data capture. Harmonisation of AfreVacc and TamoVac and UKHVC networks in order to add a gp140 protein boost to existing regimen of DNA and MVA in TaMoVac 01 trial. AfrEVac trial was conducted as an amendment to TaMoVac 01 contributing a recombinant protein boost to participants already primed with DNA/MVA. this was the first time the three HIV immunogens were combined and the strategy is one that we hope to test for efficacy, subject to funding.
Start Year 2008
 
Description CutHivac 
Organisation Charité - University of Medicine Berlin
Country Germany 
Sector Academic/University 
PI Contribution Responsibility for design of trial, analysis plan, drafting of protocol, harmonisation of data generated from other trials within network.
Collaborator Contribution Co-ordination of the network activities via regular TC and annual investigator meetings. Collation of interim and annual reports. Integration of workpackages.
Impact CutHivac001 a Phase I trial exploring the use of a novel mode of (prophylactic) vaccination in healthy volunteers fully enrolled (30 participants) in 2014, complete in 2015 and reported at two conferences: BHIVA 2016 and R4P 2016. Manuscript ready for submission. CUHTHIVTHER a Phase II HIV therapeutic vaccine trial exploring different routes for delivering a DNA vaccine including transcutaneous and intramuscular with electroporation. Fully enrolled (30 participants) and completed in 2016. Clinical Study Report submitted to Sponsor, immunology complete and manuscript in draft. CutHivac002 trials a Phase I prophylactic HIV vaccine trial exploring combination regimens with electroporation is underway and expected to complete in 2017.
Start Year 2010
 
Description CutHivac 
Organisation Fit Biotech Oy
Country Finland 
Sector Private 
PI Contribution Responsibility for design of trial, analysis plan, drafting of protocol, harmonisation of data generated from other trials within network.
Collaborator Contribution Co-ordination of the network activities via regular TC and annual investigator meetings. Collation of interim and annual reports. Integration of workpackages.
Impact CutHivac001 a Phase I trial exploring the use of a novel mode of (prophylactic) vaccination in healthy volunteers fully enrolled (30 participants) in 2014, complete in 2015 and reported at two conferences: BHIVA 2016 and R4P 2016. Manuscript ready for submission. CUHTHIVTHER a Phase II HIV therapeutic vaccine trial exploring different routes for delivering a DNA vaccine including transcutaneous and intramuscular with electroporation. Fully enrolled (30 participants) and completed in 2016. Clinical Study Report submitted to Sponsor, immunology complete and manuscript in draft. CutHivac002 trials a Phase I prophylactic HIV vaccine trial exploring combination regimens with electroporation is underway and expected to complete in 2017.
Start Year 2010
 
Description CutHivac 
Organisation Imperial College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Responsibility for design of trial, analysis plan, drafting of protocol, harmonisation of data generated from other trials within network.
Collaborator Contribution Co-ordination of the network activities via regular TC and annual investigator meetings. Collation of interim and annual reports. Integration of workpackages.
Impact CutHivac001 a Phase I trial exploring the use of a novel mode of (prophylactic) vaccination in healthy volunteers fully enrolled (30 participants) in 2014, complete in 2015 and reported at two conferences: BHIVA 2016 and R4P 2016. Manuscript ready for submission. CUHTHIVTHER a Phase II HIV therapeutic vaccine trial exploring different routes for delivering a DNA vaccine including transcutaneous and intramuscular with electroporation. Fully enrolled (30 participants) and completed in 2016. Clinical Study Report submitted to Sponsor, immunology complete and manuscript in draft. CutHivac002 trials a Phase I prophylactic HIV vaccine trial exploring combination regimens with electroporation is underway and expected to complete in 2017.
Start Year 2010
 
Description CutHivac 
Organisation IrsiCaixa Institute for AIDS Research
Country Spain 
Sector Public 
PI Contribution Responsibility for design of trial, analysis plan, drafting of protocol, harmonisation of data generated from other trials within network.
Collaborator Contribution Co-ordination of the network activities via regular TC and annual investigator meetings. Collation of interim and annual reports. Integration of workpackages.
Impact CutHivac001 a Phase I trial exploring the use of a novel mode of (prophylactic) vaccination in healthy volunteers fully enrolled (30 participants) in 2014, complete in 2015 and reported at two conferences: BHIVA 2016 and R4P 2016. Manuscript ready for submission. CUHTHIVTHER a Phase II HIV therapeutic vaccine trial exploring different routes for delivering a DNA vaccine including transcutaneous and intramuscular with electroporation. Fully enrolled (30 participants) and completed in 2016. Clinical Study Report submitted to Sponsor, immunology complete and manuscript in draft. CutHivac002 trials a Phase I prophylactic HIV vaccine trial exploring combination regimens with electroporation is underway and expected to complete in 2017.
Start Year 2010
 
Description CutHivac 
Organisation National Institute of Health and Medical Research (INSERM)
Department INSERM U543 (Cellular and Tissue Immunology Laboratory)
Country France 
Sector Public 
PI Contribution Responsibility for design of trial, analysis plan, drafting of protocol, harmonisation of data generated from other trials within network.
Collaborator Contribution Co-ordination of the network activities via regular TC and annual investigator meetings. Collation of interim and annual reports. Integration of workpackages.
Impact CutHivac001 a Phase I trial exploring the use of a novel mode of (prophylactic) vaccination in healthy volunteers fully enrolled (30 participants) in 2014, complete in 2015 and reported at two conferences: BHIVA 2016 and R4P 2016. Manuscript ready for submission. CUHTHIVTHER a Phase II HIV therapeutic vaccine trial exploring different routes for delivering a DNA vaccine including transcutaneous and intramuscular with electroporation. Fully enrolled (30 participants) and completed in 2016. Clinical Study Report submitted to Sponsor, immunology complete and manuscript in draft. CutHivac002 trials a Phase I prophylactic HIV vaccine trial exploring combination regimens with electroporation is underway and expected to complete in 2017.
Start Year 2010
 
Description CutHivac 
Organisation National Institute of Health, Mozambique
Country Mozambique 
Sector Public 
PI Contribution Responsibility for design of trial, analysis plan, drafting of protocol, harmonisation of data generated from other trials within network.
Collaborator Contribution Co-ordination of the network activities via regular TC and annual investigator meetings. Collation of interim and annual reports. Integration of workpackages.
Impact CutHivac001 a Phase I trial exploring the use of a novel mode of (prophylactic) vaccination in healthy volunteers fully enrolled (30 participants) in 2014, complete in 2015 and reported at two conferences: BHIVA 2016 and R4P 2016. Manuscript ready for submission. CUHTHIVTHER a Phase II HIV therapeutic vaccine trial exploring different routes for delivering a DNA vaccine including transcutaneous and intramuscular with electroporation. Fully enrolled (30 participants) and completed in 2016. Clinical Study Report submitted to Sponsor, immunology complete and manuscript in draft. CutHivac002 trials a Phase I prophylactic HIV vaccine trial exploring combination regimens with electroporation is underway and expected to complete in 2017.
Start Year 2010
 
Description CutHivac 
Organisation University of Washington
Department IMPACTA Peru Clinical Trials Unit
Country United States 
Sector Academic/University 
PI Contribution Responsibility for design of trial, analysis plan, drafting of protocol, harmonisation of data generated from other trials within network.
Collaborator Contribution Co-ordination of the network activities via regular TC and annual investigator meetings. Collation of interim and annual reports. Integration of workpackages.
Impact CutHivac001 a Phase I trial exploring the use of a novel mode of (prophylactic) vaccination in healthy volunteers fully enrolled (30 participants) in 2014, complete in 2015 and reported at two conferences: BHIVA 2016 and R4P 2016. Manuscript ready for submission. CUHTHIVTHER a Phase II HIV therapeutic vaccine trial exploring different routes for delivering a DNA vaccine including transcutaneous and intramuscular with electroporation. Fully enrolled (30 participants) and completed in 2016. Clinical Study Report submitted to Sponsor, immunology complete and manuscript in draft. CutHivac002 trials a Phase I prophylactic HIV vaccine trial exploring combination regimens with electroporation is underway and expected to complete in 2017.
Start Year 2010
 
Description DNAVAC 
Organisation Imperial College London
Country United Kingdom 
Sector Academic/University 
PI Contribution I contributed intellectually to the grant application by informing the clinical trial design, in particular the decision making process for going from the first stage of the investigation to the second.
Collaborator Contribution Product and immunological scientific rationale.
Impact Protocol and regulatory submission.
Start Year 2013
 
Description Dr. Sarah Joseph collaboration with Chriss Geldmacher: Epitope mapping project 
Organisation UK HIV Vaccine Consortium (UKHVC)
Country United Kingdom 
Sector Academic/University 
PI Contribution Jointing drafted the application and contributed to the design of the study. UKHVC supplied samples for cross comparison studies between other trials.
Collaborator Contribution Expert in the technology needed for the project. Major financial contribution to the project.
Impact Preliminary results presented data to UKHVC - analysis ongoing
Start Year 2014
 
Description EV02 
Organisation Eurovacc Foundation
Country Switzerland 
Sector Charity/Non Profit 
PI Contribution Design, data management and statistical analysis of this two centre Phase I HIV vaccine trial. Co-ordination of trial management and responsibility for cross site monitoring.
Collaborator Contribution Provision of DNA (University of Regensberg), NYVAC (Sanofi), Sponsorship (EuroVacc Foundation), immunological analyses (CHUV). Input into drafting of protocol.
Impact Final study report. Multiple publications in peer reviewed journals. Clear demonstration of the benefit of DNA priming.
Start Year 2006
 
Description EV02 
Organisation Lausanne University Hospital (CHUV)
Country Switzerland 
Sector Hospitals 
PI Contribution Design, data management and statistical analysis of this two centre Phase I HIV vaccine trial. Co-ordination of trial management and responsibility for cross site monitoring.
Collaborator Contribution Provision of DNA (University of Regensberg), NYVAC (Sanofi), Sponsorship (EuroVacc Foundation), immunological analyses (CHUV). Input into drafting of protocol.
Impact Final study report. Multiple publications in peer reviewed journals. Clear demonstration of the benefit of DNA priming.
Start Year 2006
 
Description EV02 
Organisation Sanofi Pasteur MSD
Country United Kingdom 
Sector Private 
PI Contribution Design, data management and statistical analysis of this two centre Phase I HIV vaccine trial. Co-ordination of trial management and responsibility for cross site monitoring.
Collaborator Contribution Provision of DNA (University of Regensberg), NYVAC (Sanofi), Sponsorship (EuroVacc Foundation), immunological analyses (CHUV). Input into drafting of protocol.
Impact Final study report. Multiple publications in peer reviewed journals. Clear demonstration of the benefit of DNA priming.
Start Year 2006
 
Description EV02 
Organisation University of Regensburg
Country Germany 
Sector Academic/University 
PI Contribution Design, data management and statistical analysis of this two centre Phase I HIV vaccine trial. Co-ordination of trial management and responsibility for cross site monitoring.
Collaborator Contribution Provision of DNA (University of Regensberg), NYVAC (Sanofi), Sponsorship (EuroVacc Foundation), immunological analyses (CHUV). Input into drafting of protocol.
Impact Final study report. Multiple publications in peer reviewed journals. Clear demonstration of the benefit of DNA priming.
Start Year 2006
 
Description EV03 
Organisation Eurovacc Foundation
Country Switzerland 
Sector Charity/Non Profit 
PI Contribution Significant intellectual input into design of protocol, CRF, database, supporting documentation, analysis plan and monitoring plan. Co-ordination of trial management and responsibility for cross site monitoring. Analysis of data.
Collaborator Contribution Eurovacc co-sponsored this Phase IIa trial with ANRS. IMPD (Eurovacc). Provision of NYVAC C (Eurovacc). Provision of DNA (University of Regensburg). Input into analysis (INSERM). Immunological assays (CHUV & ANRS).
Impact Presentation of results at international meetings (CROI, AIDS vaccine 2010, 2013). Final study report. Paper in preparation.
Start Year 2006
 
Description EV03 
Organisation French National Agency for Research on AIDS and Viral Hepatitis (ANRS)
Country France 
Sector Public 
PI Contribution Significant intellectual input into design of protocol, CRF, database, supporting documentation, analysis plan and monitoring plan. Co-ordination of trial management and responsibility for cross site monitoring. Analysis of data.
Collaborator Contribution Eurovacc co-sponsored this Phase IIa trial with ANRS. IMPD (Eurovacc). Provision of NYVAC C (Eurovacc). Provision of DNA (University of Regensburg). Input into analysis (INSERM). Immunological assays (CHUV & ANRS).
Impact Presentation of results at international meetings (CROI, AIDS vaccine 2010, 2013). Final study report. Paper in preparation.
Start Year 2006
 
Description EV03 
Organisation Imperial College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Significant intellectual input into design of protocol, CRF, database, supporting documentation, analysis plan and monitoring plan. Co-ordination of trial management and responsibility for cross site monitoring. Analysis of data.
Collaborator Contribution Eurovacc co-sponsored this Phase IIa trial with ANRS. IMPD (Eurovacc). Provision of NYVAC C (Eurovacc). Provision of DNA (University of Regensburg). Input into analysis (INSERM). Immunological assays (CHUV & ANRS).
Impact Presentation of results at international meetings (CROI, AIDS vaccine 2010, 2013). Final study report. Paper in preparation.
Start Year 2006
 
Description EV03 
Organisation Lausanne University Hospital (CHUV)
Country Switzerland 
Sector Hospitals 
PI Contribution Significant intellectual input into design of protocol, CRF, database, supporting documentation, analysis plan and monitoring plan. Co-ordination of trial management and responsibility for cross site monitoring. Analysis of data.
Collaborator Contribution Eurovacc co-sponsored this Phase IIa trial with ANRS. IMPD (Eurovacc). Provision of NYVAC C (Eurovacc). Provision of DNA (University of Regensburg). Input into analysis (INSERM). Immunological assays (CHUV & ANRS).
Impact Presentation of results at international meetings (CROI, AIDS vaccine 2010, 2013). Final study report. Paper in preparation.
Start Year 2006
 
Description EV03 
Organisation National Institute of Health and Medical Research (INSERM)
Country France 
Sector Public 
PI Contribution Significant intellectual input into design of protocol, CRF, database, supporting documentation, analysis plan and monitoring plan. Co-ordination of trial management and responsibility for cross site monitoring. Analysis of data.
Collaborator Contribution Eurovacc co-sponsored this Phase IIa trial with ANRS. IMPD (Eurovacc). Provision of NYVAC C (Eurovacc). Provision of DNA (University of Regensburg). Input into analysis (INSERM). Immunological assays (CHUV & ANRS).
Impact Presentation of results at international meetings (CROI, AIDS vaccine 2010, 2013). Final study report. Paper in preparation.
Start Year 2006
 
Description EV03 
Organisation University of Regensburg
Country Germany 
Sector Academic/University 
PI Contribution Significant intellectual input into design of protocol, CRF, database, supporting documentation, analysis plan and monitoring plan. Co-ordination of trial management and responsibility for cross site monitoring. Analysis of data.
Collaborator Contribution Eurovacc co-sponsored this Phase IIa trial with ANRS. IMPD (Eurovacc). Provision of NYVAC C (Eurovacc). Provision of DNA (University of Regensburg). Input into analysis (INSERM). Immunological assays (CHUV & ANRS).
Impact Presentation of results at international meetings (CROI, AIDS vaccine 2010, 2013). Final study report. Paper in preparation.
Start Year 2006
 
Description European HIV Vaccine Alliance (EHVA) 
Organisation National Institute of Health and Medical Research (INSERM)
Department Inserm Transfert
Country France 
Sector Public 
PI Contribution 40 partners have signed a research collaboration agreement (European Commission funded project 1st Jan 2016-31st Dec 2020). The EHVA program will develop a multidisciplinary vaccine platform (MVP) in the fields of prophylactic and therapeutic vaccines Trial protocols currently in development. Attendance at launch meeting and workpackage meetings/teleconferences. CTU providing trial management and statistical support.
Collaborator Contribution Amongst the 40 partners within the collaboration, there is expertise in immunology, virology, structural biology, viral vectors, statistics, computational and clinical science. Specific objectives within the collaboration are to build up as below, a: 1) Discovery platform - generation of novel vaccine candidates in the field of prophylactic and therapeutic vaccines inducing potent neutralizing and non-neutralizing antibody and T-cell responses. 2) Immune profiling platform - to rank novel and benchmark existing vaccine candidates in pre-clinical and human clinical trials through validated, qualified and standardized immunological assays and using advanced technologies in the profiling of the immune responses. 3) Data Management/Integration/Down-Selection Platform - to provide powerful statistical tools for the analysis and interpretation of complex data and algorithms for the selection of vaccine candidates at different stages of pre-clinical and clinical vaccine development. 2) Clinical trials platform - the primary goal is the acceleration of clinical development of novel vaccine candidates and the early prediction of failure of vaccine candidates.
Impact Country specific regulatory/ethics approvals for the therapeutic vaccine/monoclonal antibody trial are now available in Switzerland and UK and in process in France, Germany, Italy and Spain. The first joint Trial Steering and Independent Data Monitoring Committee took place in June 2018 and the first participant was enrolled on 20 February 2019. This is a multi-disciplinary collaboration.
Start Year 2016
 
Description Europrise 
Organisation ALTA
Country Italy 
Sector Private 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation European AIDS Treatment Group (EATG)
Country European Union (EU) 
Sector Public 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation GlaxoSmithKline (GSK)
Country Global 
Sector Private 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation Institute of Tropical Medicine Antwerp
Country Belgium 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation Karolinska Institute
Country Sweden 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation King's College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation Lund University
Country Sweden 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation National Institute for Biological Standards and Control (NIBSC)
Country United Kingdom 
Sector Public 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation Novartis
Country Global 
Sector Private 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation Robert Koch-Institut
Country Germany 
Sector Public 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation St George's University of London
Department Division of Clinical Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation University of Siena
Country Italy 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation University of Verona
Country Italy 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description Europrise 
Organisation University of York
Country United Kingdom 
Sector Academic/University 
PI Contribution Co-ordination and administration of workpackage dedicated to translational clinical activities. Contribution to Dissemination and Advocacy workpage also.
Collaborator Contribution Co-ordination of project, collation of reports, organisation of annual network meetings, facilitation of networking, organisation of training/workshops.
Impact Publications in peer reviewed journals, collation (and publication) of webbased toolkit to support product development from bench to bedside, facilitation of networking across other projects, dissemination, statistical support.
Start Year 2007
 
Description MucoVac 2 
Organisation Hull York Medical School
Country United Kingdom 
Sector Academic/University 
PI Contribution Design of clinical trial, CRF, database and supporting documentation. Significant intellectual input into the drafting of the protocol. Co-ordination of networking between UKHVC (product), Helpmakehistory (volunteers). Responsibility for design of monitoring plan, monitoring of trial and preparation of relevant reports. Development of analysis plan and conducting analyses. Co-ordination of final report. Co-ordination of trial management.
Collaborator Contribution Provision of Clinical and laboratory facilities/staff for clincial trial. Responsibility for drafting reports and manuscripts. Trial sponsorship (SGUL) Coordination of drafting of trial protocol. Logistical and administrative support. Provision of product and collation of investigator brochure. Collation of submission to MHRA. Immunological analyses (Imperial).
Impact Trial protocol, CRF and database. Clinical study report. Paper in presentation.
Start Year 2010
 
Description MucoVac 2 
Organisation Imperial College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Design of clinical trial, CRF, database and supporting documentation. Significant intellectual input into the drafting of the protocol. Co-ordination of networking between UKHVC (product), Helpmakehistory (volunteers). Responsibility for design of monitoring plan, monitoring of trial and preparation of relevant reports. Development of analysis plan and conducting analyses. Co-ordination of final report. Co-ordination of trial management.
Collaborator Contribution Provision of Clinical and laboratory facilities/staff for clincial trial. Responsibility for drafting reports and manuscripts. Trial sponsorship (SGUL) Coordination of drafting of trial protocol. Logistical and administrative support. Provision of product and collation of investigator brochure. Collation of submission to MHRA. Immunological analyses (Imperial).
Impact Trial protocol, CRF and database. Clinical study report. Paper in presentation.
Start Year 2010
 
Description MucoVac 2 
Organisation St George's University of London
Department Department of Cellular and Molecular Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution Design of clinical trial, CRF, database and supporting documentation. Significant intellectual input into the drafting of the protocol. Co-ordination of networking between UKHVC (product), Helpmakehistory (volunteers). Responsibility for design of monitoring plan, monitoring of trial and preparation of relevant reports. Development of analysis plan and conducting analyses. Co-ordination of final report. Co-ordination of trial management.
Collaborator Contribution Provision of Clinical and laboratory facilities/staff for clincial trial. Responsibility for drafting reports and manuscripts. Trial sponsorship (SGUL) Coordination of drafting of trial protocol. Logistical and administrative support. Provision of product and collation of investigator brochure. Collation of submission to MHRA. Immunological analyses (Imperial).
Impact Trial protocol, CRF and database. Clinical study report. Paper in presentation.
Start Year 2010
 
Description MucoVac 2 
Organisation UK HIV Vaccine Consortium (UKHVC)
Country United Kingdom 
Sector Academic/University 
PI Contribution Design of clinical trial, CRF, database and supporting documentation. Significant intellectual input into the drafting of the protocol. Co-ordination of networking between UKHVC (product), Helpmakehistory (volunteers). Responsibility for design of monitoring plan, monitoring of trial and preparation of relevant reports. Development of analysis plan and conducting analyses. Co-ordination of final report. Co-ordination of trial management.
Collaborator Contribution Provision of Clinical and laboratory facilities/staff for clincial trial. Responsibility for drafting reports and manuscripts. Trial sponsorship (SGUL) Coordination of drafting of trial protocol. Logistical and administrative support. Provision of product and collation of investigator brochure. Collation of submission to MHRA. Immunological analyses (Imperial).
Impact Trial protocol, CRF and database. Clinical study report. Paper in presentation.
Start Year 2010
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Eurovacc Foundation
Country Switzerland 
Sector Charity/Non Profit 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa). Responsible for drafting the protocol for the clinical trial and design of the trial. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Provision of product for the trial. Participating as a clinical research centre with an at risk population. Clinical trial monitoring support.
Impact Recruitment of 1237 at risk individuals through 4 of 5 actively recruiting centres as of 31Jan2019.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Imperial College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa). Responsible for drafting the protocol for the clinical trial and design of the trial. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Provision of product for the trial. Participating as a clinical research centre with an at risk population. Clinical trial monitoring support.
Impact Recruitment of 1237 at risk individuals through 4 of 5 actively recruiting centres as of 31Jan2019.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation International AIDS Vaccine Initiative (IAVI)
Country Global 
Sector Charity/Non Profit 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa). Responsible for drafting the protocol for the clinical trial and design of the trial. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Provision of product for the trial. Participating as a clinical research centre with an at risk population. Clinical trial monitoring support.
Impact Recruitment of 1237 at risk individuals through 4 of 5 actively recruiting centres as of 31Jan2019.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Karolinska Institute
Country Sweden 
Sector Academic/University 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa). Responsible for drafting the protocol for the clinical trial and design of the trial. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Provision of product for the trial. Participating as a clinical research centre with an at risk population. Clinical trial monitoring support.
Impact Recruitment of 1237 at risk individuals through 4 of 5 actively recruiting centres as of 31Jan2019.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Ludwig Maximilian University of Munich (LMU Munich)
Country Germany 
Sector Academic/University 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa). Responsible for drafting the protocol for the clinical trial and design of the trial. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Provision of product for the trial. Participating as a clinical research centre with an at risk population. Clinical trial monitoring support.
Impact Recruitment of 1237 at risk individuals through 4 of 5 actively recruiting centres as of 31Jan2019.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Medical Research Council of South Africa (MRC)
Country South Africa 
Sector Public 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa). Responsible for drafting the protocol for the clinical trial and design of the trial. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Provision of product for the trial. Participating as a clinical research centre with an at risk population. Clinical trial monitoring support.
Impact Recruitment of 1237 at risk individuals through 4 of 5 actively recruiting centres as of 31Jan2019.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Muhimbili University of Health and Allied Sciences
Country Tanzania, United Republic of 
Sector Academic/University 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa). Responsible for drafting the protocol for the clinical trial and design of the trial. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Provision of product for the trial. Participating as a clinical research centre with an at risk population. Clinical trial monitoring support.
Impact Recruitment of 1237 at risk individuals through 4 of 5 actively recruiting centres as of 31Jan2019.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation National Institute for Medical Research, Tanzania
Country Tanzania, United Republic of 
Sector Public 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa). Responsible for drafting the protocol for the clinical trial and design of the trial. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Provision of product for the trial. Participating as a clinical research centre with an at risk population. Clinical trial monitoring support.
Impact Recruitment of 1237 at risk individuals through 4 of 5 actively recruiting centres as of 31Jan2019.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation National Institute of Health, Mozambique
Country Mozambique 
Sector Public 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa). Responsible for drafting the protocol for the clinical trial and design of the trial. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Provision of product for the trial. Participating as a clinical research centre with an at risk population. Clinical trial monitoring support.
Impact Recruitment of 1237 at risk individuals through 4 of 5 actively recruiting centres as of 31Jan2019.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Uganda National Health Research Organisation
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa). Responsible for drafting the protocol for the clinical trial and design of the trial. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Provision of product for the trial. Participating as a clinical research centre with an at risk population. Clinical trial monitoring support.
Impact Recruitment of 1237 at risk individuals through 4 of 5 actively recruiting centres as of 31Jan2019.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation University College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa). Responsible for drafting the protocol for the clinical trial and design of the trial. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Provision of product for the trial. Participating as a clinical research centre with an at risk population. Clinical trial monitoring support.
Impact Recruitment of 1237 at risk individuals through 4 of 5 actively recruiting centres as of 31Jan2019.
Start Year 2018
 
Description TRANSVAC 
Organisation Braunschweig University of Technology
Department Helmholtz-Zentrum für Infektionsforschung
Country Germany 
Sector Academic/University 
PI Contribution Sarah Joseph was a lead applicant on an application made to TRANSVAC for access to deep sequencing technology.
Collaborator Contribution Unversity of Munich supplied man power and also access to samples from vaccinated and chronically infected individuals for deep sequencing. The facility at Helmholtz supplied access to deep sequencing technology and expertise.
Impact Bioinformatice Analysis is ongoing and will lead to publication and strengthening of infrastructure and expertise within the consortium.
Start Year 2012
 
Description TRANSVAC 
Organisation Ludwig Maximilian University of Munich (LMU Munich)
Department Institute of Immunology
Country Germany 
Sector Academic/University 
PI Contribution Sarah Joseph was a lead applicant on an application made to TRANSVAC for access to deep sequencing technology.
Collaborator Contribution Unversity of Munich supplied man power and also access to samples from vaccinated and chronically infected individuals for deep sequencing. The facility at Helmholtz supplied access to deep sequencing technology and expertise.
Impact Bioinformatice Analysis is ongoing and will lead to publication and strengthening of infrastructure and expertise within the consortium.
Start Year 2012
 
Description TamoVac II 
Organisation Government of Sweden
Department Swedish Institute for Infectious Disease Control
Country Sweden 
Sector Public 
PI Contribution Intellectual input into design of epidemiological studies preceding the trial, design of the trial, data management, analysis plan, CRF, drafting of protocol. Responsibility for coordination of monthly oversight, review of safety, overseeing the monitoring of clinical sites. Participation in annual investigator meetings.
Collaborator Contribution Provision of DNA and MVA. Sponsorship. Data management and statistical analysis. Building vaccine trial capacity in Tanzania and Mozambique by continued support and training to laboratory personnel to explore the responses to DNA priming and MVA boosting strategies. Co-ordination of the grant and organisation of annual investigator meetings.
Impact Protocol, CRF, data management documentation including analysis plan, database validation and all that is required for a robust data management system. Analysis workshop at MRC resulted in final analysis plan for TM 01 and design of TaMoVac II. TaMoVac II completed; Clinical Study Report and manuscript in draft.
Start Year 2010
 
Description TamoVac II 
Organisation Imperial College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Intellectual input into design of epidemiological studies preceding the trial, design of the trial, data management, analysis plan, CRF, drafting of protocol. Responsibility for coordination of monthly oversight, review of safety, overseeing the monitoring of clinical sites. Participation in annual investigator meetings.
Collaborator Contribution Provision of DNA and MVA. Sponsorship. Data management and statistical analysis. Building vaccine trial capacity in Tanzania and Mozambique by continued support and training to laboratory personnel to explore the responses to DNA priming and MVA boosting strategies. Co-ordination of the grant and organisation of annual investigator meetings.
Impact Protocol, CRF, data management documentation including analysis plan, database validation and all that is required for a robust data management system. Analysis workshop at MRC resulted in final analysis plan for TM 01 and design of TaMoVac II. TaMoVac II completed; Clinical Study Report and manuscript in draft.
Start Year 2010
 
Description TamoVac II 
Organisation Muhimbili University of Health and Allied Sciences
Department Department of Microbiology and Immunology
Country Tanzania, United Republic of 
Sector Academic/University 
PI Contribution Intellectual input into design of epidemiological studies preceding the trial, design of the trial, data management, analysis plan, CRF, drafting of protocol. Responsibility for coordination of monthly oversight, review of safety, overseeing the monitoring of clinical sites. Participation in annual investigator meetings.
Collaborator Contribution Provision of DNA and MVA. Sponsorship. Data management and statistical analysis. Building vaccine trial capacity in Tanzania and Mozambique by continued support and training to laboratory personnel to explore the responses to DNA priming and MVA boosting strategies. Co-ordination of the grant and organisation of annual investigator meetings.
Impact Protocol, CRF, data management documentation including analysis plan, database validation and all that is required for a robust data management system. Analysis workshop at MRC resulted in final analysis plan for TM 01 and design of TaMoVac II. TaMoVac II completed; Clinical Study Report and manuscript in draft.
Start Year 2010
 
Description TamoVac II 
Organisation National Institute for Medical Research, Tanzania
Department NIMR Mbeya Research Centre
Country Tanzania, United Republic of 
Sector Public 
PI Contribution Intellectual input into design of epidemiological studies preceding the trial, design of the trial, data management, analysis plan, CRF, drafting of protocol. Responsibility for coordination of monthly oversight, review of safety, overseeing the monitoring of clinical sites. Participation in annual investigator meetings.
Collaborator Contribution Provision of DNA and MVA. Sponsorship. Data management and statistical analysis. Building vaccine trial capacity in Tanzania and Mozambique by continued support and training to laboratory personnel to explore the responses to DNA priming and MVA boosting strategies. Co-ordination of the grant and organisation of annual investigator meetings.
Impact Protocol, CRF, data management documentation including analysis plan, database validation and all that is required for a robust data management system. Analysis workshop at MRC resulted in final analysis plan for TM 01 and design of TaMoVac II. TaMoVac II completed; Clinical Study Report and manuscript in draft.
Start Year 2010
 
Description TamoVac II 
Organisation National Institute for Medical Research, Tanzania
Country Tanzania, United Republic of 
Sector Public 
PI Contribution Intellectual input into design of epidemiological studies preceding the trial, design of the trial, data management, analysis plan, CRF, drafting of protocol. Responsibility for coordination of monthly oversight, review of safety, overseeing the monitoring of clinical sites. Participation in annual investigator meetings.
Collaborator Contribution Provision of DNA and MVA. Sponsorship. Data management and statistical analysis. Building vaccine trial capacity in Tanzania and Mozambique by continued support and training to laboratory personnel to explore the responses to DNA priming and MVA boosting strategies. Co-ordination of the grant and organisation of annual investigator meetings.
Impact Protocol, CRF, data management documentation including analysis plan, database validation and all that is required for a robust data management system. Analysis workshop at MRC resulted in final analysis plan for TM 01 and design of TaMoVac II. TaMoVac II completed; Clinical Study Report and manuscript in draft.
Start Year 2010
 
Description TamoVac II 
Organisation National Institute of Health, Mozambique
Country Mozambique 
Sector Public 
PI Contribution Intellectual input into design of epidemiological studies preceding the trial, design of the trial, data management, analysis plan, CRF, drafting of protocol. Responsibility for coordination of monthly oversight, review of safety, overseeing the monitoring of clinical sites. Participation in annual investigator meetings.
Collaborator Contribution Provision of DNA and MVA. Sponsorship. Data management and statistical analysis. Building vaccine trial capacity in Tanzania and Mozambique by continued support and training to laboratory personnel to explore the responses to DNA priming and MVA boosting strategies. Co-ordination of the grant and organisation of annual investigator meetings.
Impact Protocol, CRF, data management documentation including analysis plan, database validation and all that is required for a robust data management system. Analysis workshop at MRC resulted in final analysis plan for TM 01 and design of TaMoVac II. TaMoVac II completed; Clinical Study Report and manuscript in draft.
Start Year 2010
 
Description TamoVac II 
Organisation Technical University of Munich
Country Germany 
Sector Academic/University 
PI Contribution Intellectual input into design of epidemiological studies preceding the trial, design of the trial, data management, analysis plan, CRF, drafting of protocol. Responsibility for coordination of monthly oversight, review of safety, overseeing the monitoring of clinical sites. Participation in annual investigator meetings.
Collaborator Contribution Provision of DNA and MVA. Sponsorship. Data management and statistical analysis. Building vaccine trial capacity in Tanzania and Mozambique by continued support and training to laboratory personnel to explore the responses to DNA priming and MVA boosting strategies. Co-ordination of the grant and organisation of annual investigator meetings.
Impact Protocol, CRF, data management documentation including analysis plan, database validation and all that is required for a robust data management system. Analysis workshop at MRC resulted in final analysis plan for TM 01 and design of TaMoVac II. TaMoVac II completed; Clinical Study Report and manuscript in draft.
Start Year 2010
 
Description UK HIV Vaccine Consortium 
Organisation Imperial College London
Department Faculty of Medicine
Country United Kingdom 
Sector Academic/University 
PI Contribution Design including sample size rationale, drafting complementary grant applications, protocols, CRFs, trial documentation including analysis plan and submissions to competent authority, designing the central database, extracting and analysing data, preparing reports including the final Clinical Study Report.
Collaborator Contribution Intellectual contributions to the design of trials, oversight and provision of GMP and supporting documentation such as the Investigator Brochure, provision of clinical facilities and expert personnel to conduct Phase I HIV vaccine trials, central coordination of the administrative aspects of the award.
Impact GMP material for clinical trials manufactured and procured with due diligence on intellectual property. Annual UK HIV vaccine scientist meeting to review progress and comment on proposals, including meeting in March 2015 to determine whether or not to proceed to efficacy testing of current products. Several clinical trials that were being conducted in our networks were provided partial support that facilitated completion and full analyses including CUTHIVAC and TaMoVac trials.
Start Year 2008
 
Description UK HIV Vaccine Consortium 
Organisation Royal Holloway, University of London
Country United Kingdom 
Sector Academic/University 
PI Contribution Design including sample size rationale, drafting complementary grant applications, protocols, CRFs, trial documentation including analysis plan and submissions to competent authority, designing the central database, extracting and analysing data, preparing reports including the final Clinical Study Report.
Collaborator Contribution Intellectual contributions to the design of trials, oversight and provision of GMP and supporting documentation such as the Investigator Brochure, provision of clinical facilities and expert personnel to conduct Phase I HIV vaccine trials, central coordination of the administrative aspects of the award.
Impact GMP material for clinical trials manufactured and procured with due diligence on intellectual property. Annual UK HIV vaccine scientist meeting to review progress and comment on proposals, including meeting in March 2015 to determine whether or not to proceed to efficacy testing of current products. Several clinical trials that were being conducted in our networks were provided partial support that facilitated completion and full analyses including CUTHIVAC and TaMoVac trials.
Start Year 2008
 
Description UK HIV Vaccine Consortium 
Organisation University of Oxford
Country United Kingdom 
Sector Academic/University 
PI Contribution Design including sample size rationale, drafting complementary grant applications, protocols, CRFs, trial documentation including analysis plan and submissions to competent authority, designing the central database, extracting and analysing data, preparing reports including the final Clinical Study Report.
Collaborator Contribution Intellectual contributions to the design of trials, oversight and provision of GMP and supporting documentation such as the Investigator Brochure, provision of clinical facilities and expert personnel to conduct Phase I HIV vaccine trials, central coordination of the administrative aspects of the award.
Impact GMP material for clinical trials manufactured and procured with due diligence on intellectual property. Annual UK HIV vaccine scientist meeting to review progress and comment on proposals, including meeting in March 2015 to determine whether or not to proceed to efficacy testing of current products. Several clinical trials that were being conducted in our networks were provided partial support that facilitated completion and full analyses including CUTHIVAC and TaMoVac trials.
Start Year 2008
 
Description UKHVC spoke 03 (MRC DCS scheme) 
Organisation Imperial College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Oversight of clinical trial management and statistical analysis. Attendance at regular trial management group teleconferences.
Collaborator Contribution University of Surrey/Imperial College: recruitment and follow up of trial participants. Trial management & analysis: Imperial College, with oversight/input from the MRC Clinical Trials Unit at UCL.
Impact Spoke 03 trial is fully recruited, completed and reported (see publications).
Start Year 2012
 
Description UKHVC spoke 03 (MRC DCS scheme) 
Organisation Infectious Disease Research Institute (IDRI)
Country United States 
Sector Charity/Non Profit 
PI Contribution Oversight of clinical trial management and statistical analysis. Attendance at regular trial management group teleconferences.
Collaborator Contribution University of Surrey/Imperial College: recruitment and follow up of trial participants. Trial management & analysis: Imperial College, with oversight/input from the MRC Clinical Trials Unit at UCL.
Impact Spoke 03 trial is fully recruited, completed and reported (see publications).
Start Year 2012
 
Description UKHVC spoke 03 (MRC DCS scheme) 
Organisation International AIDS Vaccine Initiative (IAVI)
Department Human Immunology Laboratory, ICL
Country United States 
Sector Charity/Non Profit 
PI Contribution Oversight of clinical trial management and statistical analysis. Attendance at regular trial management group teleconferences.
Collaborator Contribution University of Surrey/Imperial College: recruitment and follow up of trial participants. Trial management & analysis: Imperial College, with oversight/input from the MRC Clinical Trials Unit at UCL.
Impact Spoke 03 trial is fully recruited, completed and reported (see publications).
Start Year 2012
 
Description UKHVC spoke 03 (MRC DCS scheme) 
Organisation University of Surrey
Country United Kingdom 
Sector Academic/University 
PI Contribution Oversight of clinical trial management and statistical analysis. Attendance at regular trial management group teleconferences.
Collaborator Contribution University of Surrey/Imperial College: recruitment and follow up of trial participants. Trial management & analysis: Imperial College, with oversight/input from the MRC Clinical Trials Unit at UCL.
Impact Spoke 03 trial is fully recruited, completed and reported (see publications).
Start Year 2012
 
Title CutHIVTher trial 
Description Full title: 'A randomised phase I/II study to assess the safety and immunogenicity of the DNA-GTU vaccine administered by two novel methods compared to placebo in HIV-infected patients on antiretroviral therapy.' Vaccine administered trancutaneously or through electroporation (enhanced intramuscular delivery). Trial participants: 30 HIV infected male and female volunteers aged 18-45 years who have been on ART for at least 6 months with 2 or more HIV plasma viral load measurements; 50 copies HIV RNA/ml prior to enrolment. Funding provided through the European Commission CUTHIVAC grant. 
Type Therapeutic Intervention - Vaccines
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2015
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Analysis still to be done, trial fully recruited and participants in follow up. 
URL http://www.hra.nhs.uk/news/research-summaries/cuthivther-001/
 
Title CutHIVac 001 trial 
Description Full title: 'A phase I clinical trial to assess the safety and immunogenicity of three HIV GTU MultiHIV DNA immunisations administered via the Intramuscular, Intradermal and Transcutanous routes in healthy male and female volunteers. Trial participants: 30 male and female volunteers aged 18-45 years old who are at low risk of HIV infection. Funding provided through the European Commission CUTHIVAC grant. 
Type Preventative Intervention - Nutrition and Chemoprevention
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2016
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Participants meeting took place January 2016. Analysis ongoing. 
URL http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14858
 
Title DNA HIV CN54 prime followed by NYVAC C boost 
Description DNA plasmid dervied from clade C CN54 which has been through Phase I and IIa trials. Significant benefit was gained from three primes (reported at CROI Feb10). 
Type Preventative Intervention - Nutrition and Chemoprevention
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2009
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Benefits of third DNA demonstrated in terms of broader and stronger immune responses. 
URL http://www.isrctn.com/ISRCTN20946776
 
Title EHVA T01(European HIV Vaccine Alliance Therapeutic Trial 01)/ANRS VRI05: 'A Phase I/II randomised therapeutic HIV vaccine trial in individuals who started antiretrovirals during primary or chronic infection 
Description An EC-funded Consortium in HIV vaccine research, this being the first trial from this grant, estimated to start recruitment mid 2018. Ethics/regulatory submissions in this pan-European consortium are underway. 
Type Therapeutic Intervention - Vaccines
Current Stage Of Development Initial development
Year Development Stage Completed 2018
Development Status Under active development/distribution
Impact Submissions to ethics/regulatory currently taking place across the pan-European Alliance with recruitment estimated to start mid 2018. UK approval by HRA February 2018. Eudract no. 2017-003081-27 
 
Title UK HVC Spoke3 
Description Clade C DNA Clade C MVA Clade C rgp140 GLA 
Type Therapeutic Intervention - Vaccines
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2015
Development Status Actively seeking support
Clinical Trial? Yes
Impact Completion of healthy volunteer HIV vaccine trial, evaluating products developed through the Wellcome Trust funded UK HVC. 
URL http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14173
 
Description AIDS vaccine 2012 oral and poster presentations 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Poster Presentation
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Audience of several thousand for the biggest international meeting about HIV vaccines. Posters were peer reviewed and 3 were selected for presentation.
website http://www.vaccineenterprise.org/conference/2012/

Priming with a "simplified regimen" of HIV-1 DNA vaccine is as good as a "standard regimen" when boosted with heterologous HIV-1 MVA vaccine in Tanzania. Patricia Munseri, Arne Kroidl, Charlotta Nilsson, Candida Moshiro, Said Aboud, Agricola Joachim, Christof Geldmacher, Eric Aris, Deus Buma, Eligius Lyamuya, Frances Gotch, Karina Godoy-Ramirez, Kisali Pallangyo, Leonard Maboko, Mary Marovich, Merlin Robb, Michael Hoelscher, Mohammed Janabi, Philipp Mann, Sarah Joseph, Sayoki Mfinanga, Wolfgang Stoehr, Fred Mhalu, Britta Wahren, Gunnel Biberfeld, Sheena McCormack, Eric Sandstrom, Muhammad Bakari



Preferential Targeting of Conserved Gag Regions After Vaccination with a Heterologous DNA Prime Modified Vaccinia Ankara Boost HIV Vaccine Regime.
Asli Bauer , Lilli Podola , Antelmo Haule, Lwithio Sudi, Charlotta Nilsson, Philipp Mann, Marco Missanga, Bahati Kaluwa, Leonard Maboko, Cornelia Lueer, Maria Mwakatima, Said Aboud, Muhammad Bakari, Jeffrey Currier, Merlin Robb, Sarah Joseph, Sheena McCormack, Eligius Lyamuya, Britta Wahren, Eric Sandström, Gunnel Biberfeld, Michael Hoelscher, Arne Kroidl, Christof Geldmacher.

Antigen-specific T Lymphocyte Responses Elicited by a DNA - MVA HIV CN54gp140 Immunization Regime Are Significantly Altered by the TLR4 Adjuvant GLA. PF McKay, AV Cope, J Swales, S Joseph, M Esteban, R Tatoud, D Carter, J Weber, RJ Shattock




Useful links made with peers and also feedback provided for funders and policy makers who were also in attendance.
Year(s) Of Engagement Activity 2012
 
Description Advocates Guide to the R4P Conference - webinar, 6th Nov. 2014 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The webinar was organised to provide feedback on R4P Conference, the first international HIV prevention conference to bring vaccines, microbicides and PREP together. I was asked to speak specifically on the take home messages regarding prevention for gay men in Europe following the iPerGay and PROUD announcements. These two trials reported early due to interim analyses demonstrating that PrEP was highly effective in reducing the risk of HIV in an event driven regimen (iPerGay) and taking acccount of any change in risk behaviours (PROUD).
There was also feedback regarding a number of Good Participatory Practice presentations after which I was able to make the point that Community Engagement has always been at the heart of preparing for large HIV prevention trials.

I was emailed after the webinar by researchers and Communtiy Advocates who agreed with the points I had made.
Year(s) Of Engagement Activity 2014
 
Description AfreVac Investigators meeting , Zanzibar 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact The final annual meeting brought together all collaborators in the project to share final results and discuss publications.

Several publications are in preparation and valuable links were made between scientists from across the Tamovac and Afrevacc networks.
Year(s) Of Engagement Activity 2010,2011,2012
 
Description CUT'HIVAC annual investigators meeting 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Annual investigators meeting

Discussions during 2012 meeting led to discussions of design of new clinical trial which will be run in Peru.
Year(s) Of Engagement Activity 2010,2011,2012,2013
 
Description Dr Sarah Joseph invited to give a special lecture to third year medical studies on HIV vaccines at Kings College 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Undergraduate students
Results and Impact Talk sparked interest and discussion about HIV vaccines among students.

-
Year(s) Of Engagement Activity 2014
 
Description Dr. Sarah Joseph attendance at Cuthivac annual Collaborators meeting, Nov 2013, Regensburg 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Progress updates on Cuthivac Consortium workpages.

-
Year(s) Of Engagement Activity 2013
 
Description Dr. Sarah Joseph attendance at Symposium on therapeutic vaccines/activators of HIV eradication, 12th Dec 2013 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Discussion about therapeutic vaccines research priorities

Informed the design of the current and future research applications
Year(s) Of Engagement Activity 2013
 
Description Dr. Sue Fleck presented at a Careers Conference, University of East London, 2nd April 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Undergraduate students
Results and Impact Well attended presentation ~100 attendees. Lots of questions and an attentive audience.
Presentation title: Working for Research Funding Organisations, Job Opportunities for Science Graduates at the Medical Research Council (MRC) Clinical Trials Unit (CTU) @ University College London (UCL)


Requests for further information.
Year(s) Of Engagement Activity 2014
 
Description EDCTP HIV Stakeholders meeting, Sep 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact There were about 100 delegates from Africa, Europe and the US that attended this meeting. The majority were senior and influential academics or from normative agencies.

I am uniquely privileged to be working in microbicides, vaccines and PrEP to reduce the risk of HIV, and across the spectrum of product development from Phase I through to implementation. This was a excellent opportunity to provide a perspective balanced by the breadth and depth of my clinical trial experience.
Year(s) Of Engagement Activity 2013
URL http://www.edctp.org
 
Description Help Make History website www.helpmakehistory.mrc.ac.uk to increase interest in public participation in vaccine trials/information sharing 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Increase in number of registrants to Help Make History database of potential participants to vaccine trials. Increase in number of direct enquiries relating to participation in vaccine trials.

Registration to the Help Make History database of potential participants to vaccine trials has increased, along with the number of direct enquiries. Cuthivac 001 trial is now fully enrolled (as of 6th Nov 2014) as as direct result of this engagement, along with profiling of vaccine recruitment on social media.
Year(s) Of Engagement Activity 2012,2013,2014
URL http://www.helpmakehistory.mrc.ac.uk
 
Description Inaugural lecture 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact About 200 people from a range of disciplines and including the general public and school children attended and it was an opportunity to raise awareness of the ongoing HIV epidemic, the dramatic advances in biomedical interventions for the prevention of HIV and the importance of behaviour.

The lecture was videoed and posted on YouTube and tweeted.
Year(s) Of Engagement Activity 2013
 
Description Lecture to medical students at Guys and St Thomass 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Undergraduate students
Results and Impact I gave an overview of HIV vaccines to medical students, highlighting the work of the UKHVC

Course organiser invited Sarah Joseph to give lecture to medical students on HIV vaccines as part of their virology moduel.
Year(s) Of Engagement Activity 2012,2013
 
Description Media - Interview for article in The Guardian supplement The Scene: Help make history by volunteering for HIV vaccine clinical trials; published 2nd Aug 2014 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Prof. Robbin Shattock interviewed, article created promoting recuitment to HIV vaccine trials.

Increase in requests for participation in Cuthivac 001 HIV vaccine trial, fully recruited as of 6th Nov 2014.
Year(s) Of Engagement Activity 2014
 
Description Presentation at the UK HIV Community Advisory Board meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact approx 50 advocates attended an all day meeting. Presentation "why is it so difficult to find an effective HIV vaccine" followed by an introduction to the Help make History website for healthy HIV vaccine trial volunteers

Interest shown in helping develop future studies
Year(s) Of Engagement Activity 2009
 
Description Prof. Robin Shattock presented at the All-Party Parliamentary Group meeting focussed on AIDS, TB and Malaria, 25th Feb 2014 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact Professor Robin Shattock, Faculty of Medicine, Department of Medicine, Imperial College. Chairman of Mucosal infection and immunity and member of IAVI's Scientific Advisory Committee. Prof. Shattock addressed resistance to ARVs, therapeutic vaccines, the role of PrEP and the development of preventive vaccines.



Prof. Robin Shattock presented the challenges with resistance to ARVs which led on to discussions about why additional prevention options including microbicides and vaccines are needed. Slides on the UK HIV Resistance Database were presented also. Greater understanding gained by the APPG.
Year(s) Of Engagement Activity 2014
URL http://www.lstmliverpool.ac.uk/events/february-2014/25-feb-all-party-parliamentary-group-on-malaria-...
 
Description Satellite at AIDS vaccine 2012 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Talk invited for satellite meeting organised by Bill and Melinda Gates and EDCTP to provide feedback on AfreVacc / TaMoVac collaboration.

The talk at the EDCTP satellite was organised to inform their next round of funding.
Year(s) Of Engagement Activity 2012
 
Description TaMoVac inestigators meeting, Zanzibar 2012, Mozambique 2013 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact This annual meeting is an opportunity for ~100 collaborators to share results and discuss progress of the multicentre project.

Volunteers from HIV vaccine trials attended this years meeting and were able to discuss their experiences with members of the team from different sites. The feedback from everyone was encouraging.
Year(s) Of Engagement Activity 2009,2010,2011,2012,2013
 
Description Use of Social Media for recruitment to HIV prevention research projects: Cuthivac 01 trial 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Use of Twitter and Facebook for information sharing and to stimulate recruitment to the Cuthivac 01 vaccine study.

An increase in enquiries. Both studies now fully enrolled.
Year(s) Of Engagement Activity 2013,2014
 
Description Vaccine projects update at MRC CTU at Infections General Staff Meeting, 22nd Sept 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Rosie Belcher presentation: Help Make History: A mixed methods descriptive study of factors affecting recruitment to phase I HIV vaccine trials
Sarah Joseph presentation: Vaccine trials update

Questions from the audience
Year(s) Of Engagement Activity 2014