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
- MRC Clinical Trials Unit (Lead Research Organisation)
- National Institute for Biological Standards and Control (NIBSC) (Collaboration)
- European AIDS Treatment Group (EATG) (Collaboration)
- Institute of Tropical Medicine (Collaboration)
- IrsiCaixa Institute for AIDS Research (Collaboration)
- Royal Holloway, University of London, United Kingdom (Collaboration)
- University of KwaZulu-Natal (Collaboration)
- Braunschweig University of Technology (Collaboration)
- Pasteur Merieux Serums (Collaboration)
- Gilead Sciences, Inc. (Collaboration)
- ALTA (Collaboration)
- Muhimbili University of Health and Allied Sciences (Collaboration)
- National Institute of Health, Mozambique (Collaboration)
- National Institute of Health and Medical Research (INSERM) (Collaboration)
- Novartis (Collaboration)
- University Hospital Centre Vaudois (Collaboration)
- University of Siena (Collaboration)
- Eurovacc Foundation (Collaboration)
- UK HIV Vaccine Consortium (UKHVC) (Collaboration)
- Medical Research Council of South Africa (MRC) (Collaboration)
- University of Oxford, United Kingdom (Collaboration)
- Washington University in St. Louis (Collaboration)
- University of Regensburg, Germany (Collaboration)
- National Institute for Medical Research (Collaboration)
- Karolinska Institute, Sweden (Collaboration)
- St George's University of London, United Kingdom (Collaboration)
- Imperial College London, United Kingdom (Collaboration)
- Infectious Disease Research Institute (IDRI) (Collaboration)
- GlaxoSmithKline (GSK) (Collaboration)
- Robert Koch Institute, Germany (Collaboration)
- Ludwig Maximilians University Munich (Collaboration)
- University of Verona (Collaboration)
- University of York, United Kingdom (Collaboration)
- Technical University of Munich (Collaboration)
- University of Surrey, United Kingdom (Collaboration)
- International AIDS Vaccine Initiative (IAVI) (Collaboration)
- Uganda National Health Research Organisation (Collaboration)
- French National Agency for Research on AIDS and Viral Hepatitis (ANRS) (Collaboration)
- Lund University (Collaboration)
- Hull York Medical School (Collaboration)
- Government of Sweden (Collaboration)
- Charité - University of Medicine Berlin (Collaboration)
- King's College London, United Kingdom (Collaboration)
- Fit Biotech Oy (Collaboration)
People |
ORCID iD |
| Sheena McCormack (Principal Investigator) |
Publications
Cheeseman HM
(2018)
Combined Skin and Muscle DNA Priming Provides Enhanced Humoral Responses to a Human Immunodeficency Virus Type 1 Clade C Envelope Vaccine.
in Human gene therapy
Haidari G
(2017)
Combined skin and muscle vaccination differentially impact the quality of effector T cell functions: the CUTHIVAC-001 randomized trial.
in Scientific reports
Haire B
(2013)
Ethical considerations in determining standard of prevention packages for HIV prevention trials: examining PrEP.
in Developing world bioethics
Harari A
(2008)
An HIV-1 clade C DNA prime, NYVAC boost vaccine regimen induces reliable, polyfunctional, and long-lasting T cell responses.
in The Journal of experimental medicine
| 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 | Netherlands |
| 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 | Netherlands |
| 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 | 03/2008 |
| 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 | Netherlands |
| 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 | Academic/University |
| 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 | 06/2012 |
| End | 09/2013 |
| Description | UKHIV Vaccine Consortium spoke 003 trial: MRC DCS scheme |
| Amount | £66,415 (GBP) |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 06/2012 |
| 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. Database cleaned and locked after early closure of EHVA-T01. |
| Type Of Material | Database/Collection of data |
| Year Produced | 2018 |
| Provided To Others? | No |
| Impact | No impact. Database now locked. |
| 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 |
| Country | Uganda |
| 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 | 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 | 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 | 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 | Charity/Non Profit |
| 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 | 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 | 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 2016-30th June 2023). 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 EHVA T01 were obtained in Switzerland and UK and the first participant enrolled when the Biotech provider of the DNA vaccine went into liquidation. The trial had to be closed and a new protocol submitted, EHVA T02. This provided an opportunity to revisit the design in light of data from other clinical trials. EHVA T02 has approval in Switzerland and UK, and is in progress in France, Germany, Spain and Italy. The second Trial Steering and Independent Data Monitoring Committees took place in October and December 2019 respectively. |
| 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 | Belgium |
| Sector | Charity/Non Profit |
| 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 | Charity/Non Profit |
| 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 | 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 | 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 |
| 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 |