Blood borne viruses
Lead Research Organisation:
University College London
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.
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.
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.
Organisations
- University College London, United Kingdom (Collaboration, Lead Research Organisation)
- National Institute for Medical Research (Collaboration)
- Karolinska Institute, Sweden (Collaboration)
- Imperial College London, United Kingdom (Collaboration)
- Ludwig Maximilians University Munich (Collaboration)
- Eastern Virginia Medical School (Collaboration)
- University of KwaZulu-Natal (Collaboration)
- Gilead Sciences, Inc. (Collaboration)
- International AIDS Vaccine Initiative (IAVI) (Collaboration)
- Muhimbili University of Health and Allied Sciences (Collaboration)
- National Institute of Health, Mozambique (Collaboration)
- Uganda National Health Research Organisation (Collaboration)
- University Hospital Centre Vaudois (Collaboration)
- Eurovacc Foundation (Collaboration)
- Medical Research Council of South Africa (MRC) (Collaboration)
Publications

Arnold-Forster D
(2022)
Perceptions and Practicalities Influencing Pre-exposure Prophylaxis Adherence Among Men Who Have Sex with Men in England.
in AIDS and behavior

Arrigoni FIF
(2023)
Impact of sub-optimal HIV viral control on activated T-cells: an earnest sub study.
in AIDS (London, England)

Arum C
(2021)
Homelessness, unstable housing, and risk of HIV and hepatitis C virus acquisition among people who inject drugs: a systematic review and meta-analysis.
in The Lancet. Public health

Asad H
(2021)
Mortality and AIDS-defining events among young people following transition from paediatric to adult HIV care in the UK.
in HIV medicine

Atkinson A
(2021)
No need for secondary Pneumocystis jirovecii pneumonia prophylaxis in adult people living with HIV from Europe on ART with suppressed viraemia and a CD4 cell count greater than 100 cells/µL.
in Journal of the International AIDS Society

Beyrer C
(2022)
Pre-Exposure Prophylaxis for HIV Infection as a Public Health Tool
in Journal of Law, Medicine & Ethics

Caby F
(2021)
CD4/CD8 Ratio and the Risk of Kaposi Sarcoma or Non-Hodgkin Lymphoma in the Context of Efficiently Treated Human Immunodeficiency Virus (HIV) Infection: A Collaborative Analysis of 20 European Cohort Studies.
in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America


Chappell E
(2022)
Children living with HIV in Europe: do migrants have worse treatment outcomes?
in HIV medicine
Description | BHIVA/BASHH PrEP guidelines |
Geographic Reach | National |
Policy Influence Type | Membership of a guideline 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. |
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 | 07/2021 |
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 | 04/2022 |
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 |