Blood borne viruses

Lead Research Organisation: University College London
Department Name: UNLISTED

Abstract

Infectious diseases are still major causes of deaths and illnesses worldwide. In our Blood Borne viruses programme we have focussed on hepatitis C virus (HCV) and Human Immunodeficiency Virus (HIV). These are the blood borne viruses with the greatest global burden of deaths and illness. Our studies are in line with the strategic priorities of the World Health Organization. Our results change guidelines, policy and practice across the age range. Most of our infection trials involve collaborations with partners and networks worldwide. We pursue collaborations which have high global impact and in which we can shape the science now and in the future, drive the research agenda, and play a key role in the research trial design, conduct and analysis. Examples of the impact of our research include:
1. license approval of new antiretroviral treatments for children with HIV, with resulting improved outcomes
2. a package of affordable anti-infective medicines, which reduces mortality in those presenting with AIDS
3. preventing HIV infection by taking just one antiretroviral pill a day.
Together these trials contribute to the WHO targets of eliminating AIDS globally.

Technical Summary

Infectious diseases remain major causes of mortality and morbidity worldwide. In the Blood Borne viruses (BBV) programme we have focussed on hepatitis C virus (HCV) and Human Immunodeficiency Virus (HIV), the blood borne viruses with the greatest global burden of mortality and morbidity. Chronic BBV infections also have indirect effects, by increasing the risks or adverse consequences of non-communicable diseases. It therefore remains essential that prevention efforts across the spectrum of key BBVs continues, especially if the WHO targets for global elimination are to be achieved. Our studies are aligned with the major strategic priorities of the World Health Organization, and results are expected to, and have change guidelines, policy and practice across the age spectrum.
In particular, the advent of new highly effective direct acting antivirals against hepatitis C provides a unique opportunity for large strategic trials to identify how these drugs might be used best to support the elimination agenda and increase access, in low-and-middle-income countries and in the challenging “hard-to-reach-and-treat” populations. Our research objectives are to exploit new, short effective oral regimens to test strategies which might successfully cure patients whilst minimising drug exposure and/or course duration, including stratified medicine approaches, in large randomised trials. We also aim to develop a trial to cure hepatitis C virus in pregnant women living with HCV and prevent vertical HCV transmission.
In HIV infection, the prevention trials that we have led have played a major role in reducing new HIV infections, and we have implemented novel designs to improve efficiency in both the vaccine (MAMS designs) and self-testing (electronic randomisation and follow-up) areas. We have also completed a large randomised trial in late HIV presenters, identifying an adjunctive package of prophylaxis which reduced mortality after starting treatment by 25%. We continue to address relevant questions to the management of HIV-infected children, particularly focussing on questions relating to the efficacy, toxicity and pharmacokinetics of antiretroviral drugs in new fixed dose combination solid dispersible formulations, using new ratios and following WHO-recommended weight-bands. However, the continued and improving success of treatment of vertically infected HIV-infected children surviving into adolescence as a consequence of antiretroviral therapy, has to be balanced with the poorer treatment outcomes in adolescents, and emphasises the need to investigate more acceptable, less toxic, treatment and prevention strategies to improve long-term health outcomes in this population, including the utility of long-acting injectable antiretrovirals. This objective will be achieved through the design, conduct and analysis of large randomised trials in low and middle-income settings.

People

ORCID iD

Publications

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Related Projects

Project Reference Relationship Related To Start End Award Value
MC_UU_00004/01 01/04/2021 31/03/2026 £5,186,000
MC_UU_00004/02 Transfer MC_UU_00004/01 01/04/2021 31/03/2026 £4,446,000
MC_UU_00004/03 Transfer MC_UU_00004/02 01/04/2021 31/03/2026 £4,999,000
MC_UU_00004/04 Transfer MC_UU_00004/03 01/04/2021 31/03/2026 £5,315,000
MC_UU_00004/05 Transfer MC_UU_00004/04 01/04/2021 31/03/2026 £3,107,000
MC_UU_00004/06 Transfer MC_UU_00004/05 01/04/2021 31/03/2026 £2,889,000
MC_UU_00004/07 Transfer MC_UU_00004/06 01/04/2021 31/03/2026 £2,369,000
MC_UU_00004/08 Transfer MC_UU_00004/07 01/04/2021 31/03/2026 £2,270,000
MC_UU_00004/09 Transfer MC_UU_00004/08 01/04/2021 31/03/2026 £2,160,000
 
Description BHIVA/BASHH PrEP guidelines
Geographic Reach National 
Policy Influence Type Participation in a guidance/advisory committee
Impact The preceding Position Statement, PROUD film roadshow and coordinated efforts by the Sexual Health Clinics and Community Organisations to raise awareness had already resulted in a decline in new HIV infections amongst men who have sex with men. However, the BHIVA/BASHH guidelines reached a wider audience particularly clinicians practising in more rural environments enabling them to feel more confident about prescribing. The guidelines were released whilst the PrEP Impact trial was recruiting and a considerable effort was made to raise awareness amongst key populations who had not participate in previous clinical research and were less aware of the benefits. The guidelines are undergoing an update and in 2022 there was an opportunity to address the challenge for PrEP users who have taken a break from their PrEP and have a risk at a time when there is no drug, or too little to be effective on board. The PrEP writing group accepted the importance of taking drug as soon as possible and therefore making use of the drug in hand.
URL https://www.bhiva.org/file/5b729cd592060/2018-PrEP-Guidelines.pdf
 
Description Membership of WHO Guidelines Development Group (GDG) for Treating and Preventing HIV Infection
Geographic Reach Multiple continents/international 
Policy Influence Type Membership of a guideline committee
Impact WHO publishes new Consolidated HIV guidelines for prevention, treatment, service delivery & monitoring in July 2021. These recommendations intend to optimize HIV treatment monitoring, provide more options for HIV combination prevention and further harmonize ART for those initiating treatment for tuberculosis among coinfected individuals and for people being evaluated for rapid ART initiation, including same-day start. The implementation of these recommendations within the overall public health approach will support further reductions in HIV incidence and HIV-associated illness and death.
URL https://www.who.int/publications/i/item/9789240031593
 
Guideline Title CONSOLIDATED GUIDELINES ON HIV PREVENTION, TESTING, TREATMENT, SERVICE DELIVERY AND MONITORING: RECOMMENDATIONS FOR A PUBLIC HEALTH APPROACH
Description ODYSSEY results discussed in WHO guidelines
Geographic Reach Multiple continents/international 
Policy Influence Type Citation in clinical guidelines
URL https://www.who.int/publications/i/item/9789240031593
 
Description Operational Guidance on the implementation, standards, and monitoring of PrEP in the EU/EEA and UK
Geographic Reach Europe 
Policy Influence Type Contribution to new or Improved professional practice
Impact The operational guidance was released in 2021 and is in use throughout the EU/EEA and UK
URL https://www.ecdc.europa.eu/sites/default/files/documents/HIV-Pre-Exposure-Prophylaxis-in-the-EU-EEA-...
 
Description Penta English and Russian courses in Paediatric HIV, hepatitis and congenital infections - online modules and tutorial support
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact Penta training courses reach wide audiences of healthcare workers in Western and Eastern Europe and Central Asia providing medical care to children and adolescents living with HIV.
 
Description Working group for Penta / EACS HIV guidelines, v 11.0
Geographic Reach Multiple continents/international 
Policy Influence Type Membership of a guideline committee
Impact Inclusion of paediatric HIV guidelines in the adult European AIDS Clinical Society improved the access and visibility of paediatric HIV guidelines for healthcare workers and practitioners providing medical care to children and adolescents living with HIV.
URL https://www.eacsociety.org/guidelines/eacs-guidelines/
 
Description Long-Acting Treatment in Adolescents (LATA) A randomised open-label 2-arm 96 week trial in virologically suppressed HIV-1-positive adolescents aged 12-19 years of age in Sub-Saharan Africa
Amount € 5,698,081 (EUR)
Funding ID LATA_TMC278HTX3004-LATA-UCL-Pett 
Organisation Janssen Pharmaceutica NV 
Sector Private
Country Belgium
Start 12/2021 
End 12/2026
 
Description Safety and effectiveness of dolutegravir in children and adolescents with HIV in Europe and Thailand: a European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) study proposal
Amount € 2,005,380 (EUR)
Organisation Viiv Healthcare 
Sector Private
Country United Kingdom
Start 08/2021 
End 04/2025
 
Description Safety and effectiveness of tenofovir alafenamide fumarate (TAF) -based therapy in children and adolescents living with HIV in Eastern and Western Europe and Thailand: a European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) study
Amount € 802,750 (EUR)
Organisation Gilead Sciences, Inc. 
Sector Private
Country United States
Start 05/2022 
End 04/2024
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Eastern Virginia Medical School
Country United States 
Sector Academic/University 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Eurovacc Foundation
Country Switzerland 
Sector Charity/Non Profit 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Gilead Sciences, Inc.
Country United States 
Sector Private 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Imperial College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation International AIDS Vaccine Initiative (IAVI)
Country Global 
Sector Charity/Non Profit 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Karolinska Institute
Country Sweden 
Sector Academic/University 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Lausanne University Hospital (CHUV)
Country Switzerland 
Sector Hospitals 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Ludwig Maximilian University of Munich (LMU Munich)
Country Germany 
Sector Academic/University 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Medical Research Council of South Africa (MRC)
Country South Africa 
Sector Public 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Muhimbili University of Health and Allied Sciences
Country Tanzania, United Republic of 
Sector Academic/University 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation National Institute for Medical Research, Tanzania
Country Tanzania, United Republic of 
Sector Public 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation National Institute of Health, Mozambique
Country Mozambique 
Sector Public 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation Uganda National Health Research Organisation
Country Uganda 
Sector Public 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation University College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description PrEPVacc: 'A combination, comparative efficacy study in Africa of diverse HIV-1 subtype-C DNA-MVA-protein/adjuvant vaccine regimens with pre-exposure prophylaxis' 
Organisation University of KwaZulu-Natal
Department KwaZulu-Natal Research Institute for Tuberculosis and HIV (K-RITH)
Country South Africa 
Sector Charity/Non Profit 
PI Contribution Mentorship of MRC/UVRI and LSHTM team in Uganda where the Registration Cohort database is held for five participating centres (4 countries in sub-Saharan Africa), including a week of training in 2019. Responsible for drafting the protocol for the clinical trial and design of the trial and coordination of trial management team. Addition of the PrEP randomisation to compare F/TAF to F/TDF in populations at risk of acquiring HIV through heterosexual sex.
Collaborator Contribution Trial coordination and data management (UNHRO) Provision of product for the trial (Imperial and EuroVacc) Participating as a clinical research centre with an at risk population (NIMR-MMRC, MRC SA, CISPOC/INS and MUHAS). Clinical trial monitoring support (IAVI). Clinical support (LMU) Laboratory support (KI, LMU, IAVI, CHUV, EVMS, AHRI). Social Science support (UNHRO, AHRI). Gilead (provision of drug and funds for social science and laboratory support).
Impact Recruitment of 2510 at risk individuals through 5 actively recruiting centres as of 20Jan2021. PrEPVacc clinical trial 'A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.' https://clinicaltrials.gov/ct2/show/NCT04066881 ClinicalTrials.gov Identifier: NCT04066881 The first participant was enrolled in Masaka, Uganda on 15th December 2020. This 'three in one' trial is testing two ways to prevent HIV - vaccines and PrEP - in four sites in three countries in Sub-Saharan Africa: South Africa; Tanzania; and Uganda.
Start Year 2018
 
Description Membership of the WHO Paediatric Antiretroviral Drug Optimisation (PADO) group 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact Providing expert opinion, related to development of new drugs/formulations for children.
Year(s) Of Engagement Activity 2018,2021
 
Description Membership of the WHO Paediatric Antiretroviral Working Group (PAWG) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact Providing expert opinion for the WHO Paediatric Antiretroviral Working Group (PAWG), related to prevention, treatment and development of new drugs for children.
Year(s) Of Engagement Activity 2016,2017,2018,2019,2020,2021
 
Description Membership of the WHO Paediatric Working Group on Viral Hepatitis (PWGH) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact Providing expert opinion for the WHO Paediatric Working Group on Viral Hepatitis (PWGH), related to prevention, treatment and development of new drugs for children.
Year(s) Of Engagement Activity 2020,2021
 
Description ODYSSEY animated abstract 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact This animation summarises the results of the main ODYSSEY paper, showing dolutegravir-based ART was superior to standard of care regimens for children living with HIV.
Year(s) Of Engagement Activity 2021
URL https://vimeo.com/618932932
 
Description ODYSSEY briefing paper 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact This briefing paper summarises the results of the ODYSSEY trial, and presents recommendations for policy and practice.
Year(s) Of Engagement Activity 2021
URL https://www.mrcctu.ucl.ac.uk/media/2044/odyssey-briefing-paper-241121.pdf
 
Description Paediatric ARV Drug Optimization (PADO) 5th meeting: Invited talk on New Strategies to Optimise ARV Treatment 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact PADO group is WHO-led international group of different stakeholders aimed to define antiretroviral drugs for medium and long-term development for children living with HIV. PADO group meetings are held every 1-2 years. The talk was a joint presentation with Dr Anton Pozniak on pros and cons for dual regimens, including injectable regimens, for treatment of HIV (with focus on LMICs).
Year(s) Of Engagement Activity 2021
 
Description Paediatric HIV & Hepatitis special theme day, the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM): Invited talk "Long-acting and dual agent antiretroviral regimens" 10 Sep 2021 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presented overview of evidence on dual treatment regimens in HIV for ART-initiation and maintenance, including updates on paediatric studies.
Year(s) Of Engagement Activity 2021
 
Description Penta English and Russian courses in Paediatric HIV, hepatitis and congenital infections - preparation and update of online modules and tutorial support 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Incorporating latest evidence from the research studies, including those conducted by MRC CTU at UCL, in the interactive modules on Epidemiology and natural Infection; HIV: diagnosis, staging and role of co-infections and malignancy; Co-infections: Hepatitis and TB. Tutorial support during annually conducted courses. Lectures at the residential and virtual (from 2020) courses.
Year(s) Of Engagement Activity 2013,2014,2015,2016,2017,2018,2019,2020,2021
 
Description Support to European Member States on implementation and monitoring of pre-exposure prophylaxis for HIV 
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 intention of this activity is to support public health practitioners in the EU member states and UK nations to implement PrEP services and monitor them. Two workshops are planned, and a survey of the current status, gaps and needs. The goal is to produce guidance, based on evidence in the literature and expert opinion, that outlines multiple mechanisms for delivering and monitoring PrEP mapped to a range of epidemic patterns and healthcare settings so that member states can identify the most suitable mechanism to adopt.

This activity was awarded as a tender from the European Centre for Disease Prevention and Control.

The output was operational guidance for countries in the EU/EEA and UK with case examples to reflect the diversity of services for sexual health and PrEP.
Year(s) Of Engagement Activity 2019
URL https://www.ecdc.europa.eu/en/news-events/ecdc-releases-operational-guidance-HIV-PrEP-eueea-uk