A combination efficacy study in Africa of two DNA-MVA- or DNA- Env protein HIV-1 vaccine regimens with pre-exposure prophylaxis (PrEP) – supplementary funding for MPLA-Liposomes
Lead Research Organisation:
Imperial College London
Department Name: UNLISTED
Abstract
Abstracts are not currently available in GtR for all funded research. This is normally because the abstract was not required at the time of proposal submission, but may be because it included sensitive information such as personal details.
Technical Summary
Supplementary funding for the acquisition of MPLA-Liposomes for the ongoing PrEPVacc study a Phase IIb, three-arm, two-stage HIV efficacy vaccine trial with a second randomisation to compare the newer PrEP drug Descovy to the established standard for PrEP, Truvada.
Organisations
- Imperial College London (Lead Research Organisation)
- Africa Health Research Institute (Collaboration)
- Instituto Nacional de Saúde (Collaboration)
- Muhimbili University of Health and Allied Sciences (Collaboration)
- University College London (Collaboration)
- National Institute for Medical Research, Tanzania (Collaboration)
- Karolinska Institute (Collaboration)
- Medical Research Council of South Africa (MRC) (Collaboration)
- Lausanne University Hospital (CHUV) (Collaboration)
- Ludwig Maximilian University of Munich (LMU Munich) (Collaboration)
- Eurovacc Foundation (Collaboration)
- MRC/UVRI Uganda Research Unit on AIDS (Collaboration)
People |
ORCID iD |
| Jonathan Weber (Principal Investigator) |
Publications
Donnell D
(2024)
Study design approaches for future active-controlled HIV prevention trials.
in Statistical communications in infectious diseases
Kansiime S
(2024)
Challenges in estimating the counterfactual placebo HIV incidence rate from a registration cohort: The PrEPVacc trial.
in Clinical trials (London, England)
Kusemererwa S
(2021)
Predictors of oral pre-exposure prophylaxis (PrEP) uptake among individuals in a HIV vaccine preparedness cohort in Masaka, Uganda.
in Medicine
| Description | PrEPVacc PrEP Dosing Advice Project |
| Geographic Reach | Africa |
| Policy Influence Type | Contribution to new or improved professional practice |
| Description | Additional funding for PrEPVacc |
| Amount | € 1,624,582 (EUR) |
| Organisation | Medical Research Council (MRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2022 |
| End | 12/2024 |
| Description | PrEPVacc Supplementary funding |
| Amount | $649,308 (USD) |
| Organisation | Gilead Sciences, Inc. |
| Sector | Private |
| Country | United States |
| Start | 01/2020 |
| End | 12/2024 |
| Description | PrEPVacc shortfall funding |
| Amount | € 1,000,000 (EUR) |
| Organisation | German Federal Ministry of Education and Research |
| Sector | Public |
| Country | Germany |
| Start | 01/2022 |
| End | 12/2022 |
| Description | PrEPVacc consortium |
| Organisation | Africa Health Research Institute |
| Country | South Africa |
| Sector | Charity/Non Profit |
| PI Contribution | Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study. |
| Collaborator Contribution | UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management |
| Impact | The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet. |
| Start Year | 2018 |
| Description | PrEPVacc consortium |
| Organisation | Eurovacc Foundation |
| Country | Switzerland |
| Sector | Charity/Non Profit |
| PI Contribution | Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study. |
| Collaborator Contribution | UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management |
| Impact | The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet. |
| Start Year | 2018 |
| Description | PrEPVacc consortium |
| Organisation | Instituto Nacional de Saúde |
| Country | Mozambique |
| Sector | Public |
| PI Contribution | Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study. |
| Collaborator Contribution | UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management |
| Impact | The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet. |
| Start Year | 2018 |
| Description | PrEPVacc consortium |
| Organisation | Karolinska Institute |
| Country | Sweden |
| Sector | Academic/University |
| PI Contribution | Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study. |
| Collaborator Contribution | UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management |
| Impact | The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet. |
| Start Year | 2018 |
| Description | PrEPVacc consortium |
| Organisation | Lausanne University Hospital (CHUV) |
| Country | Switzerland |
| Sector | Hospitals |
| PI Contribution | Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study. |
| Collaborator Contribution | UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management |
| Impact | The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet. |
| Start Year | 2018 |
| Description | PrEPVacc consortium |
| Organisation | Ludwig Maximilian University of Munich (LMU Munich) |
| Country | Germany |
| Sector | Academic/University |
| PI Contribution | Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study. |
| Collaborator Contribution | UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management |
| Impact | The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet. |
| Start Year | 2018 |
| Description | PrEPVacc consortium |
| Organisation | MRC/UVRI Uganda Research Unit on AIDS |
| Country | Uganda |
| Sector | Public |
| PI Contribution | Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study. |
| Collaborator Contribution | UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management |
| Impact | The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet. |
| Start Year | 2018 |
| Description | PrEPVacc consortium |
| Organisation | Medical Research Council of South Africa (MRC) |
| Country | South Africa |
| Sector | Public |
| PI Contribution | Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study. |
| Collaborator Contribution | UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management |
| Impact | The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet. |
| Start Year | 2018 |
| Description | PrEPVacc consortium |
| Organisation | Muhimbili University of Health and Allied Sciences |
| Country | Tanzania, United Republic of |
| Sector | Academic/University |
| PI Contribution | Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study. |
| Collaborator Contribution | UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management |
| Impact | The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet. |
| Start Year | 2018 |
| Description | PrEPVacc consortium |
| Organisation | National Institute for Medical Research, Tanzania |
| Department | NIMR Mbeya Research Centre |
| Country | Tanzania, United Republic of |
| Sector | Academic/University |
| PI Contribution | Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study. |
| Collaborator Contribution | UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management |
| Impact | The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet. |
| Start Year | 2018 |
| Description | PrEPVacc consortium |
| Organisation | University College London |
| Department | Medical Research Council Clinical Trials Unit (MRC CTU) at UCL |
| Country | United Kingdom |
| Sector | Public |
| PI Contribution | Imperial College is the PrEPVacc project co-ordinator. Imperial is responsible for Project, Financial and IMP management as well as leading the operational aspects of the study. |
| Collaborator Contribution | UCL-Clinical support to MRC/UVRI MRC/UVRI-Co-ordinating site of Clinical Study and registration cohort study site and clinical centre INS-registration cohort study site MRC-SA-registration cohort study site and clinical centre NIMR-MMRC (Mbeya)-registration cohort study site and clinical centre MUHAS-registration cohort study site and clinical centre KI-capacity building LMU-lab capacity building CHUV-provision of DNA vaccine EVF- IMP management |
| Impact | The PrEPVacc consortium is multi-disciplinary consisting of clinicians, scientists and social scientists. The trial is still actively recruiting so there are no outputs yet. |
| Start Year | 2018 |
| Title | PrEPVacc clinical trial |
| Description | PrEPVacc was an international, multicentre, double-blind vaccine study will be a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens with placebo control. The study was funded by EDCTP with supplementary funding provided by the MRC and the German government. Pre-screening for risk and HIV status took place as part of a Registration Cohort which preceded and continued in parallel to PrEPVacc enrolments. This gave HIV negative volunteers time to learn about the PrEPVacc trial and facilitate timely enrolment. Clinical screening for the vaccine trial took place during the 8 weeks prior to randomisation. Eligible participants were enrolled at week 0 and randomised to one of three vaccine arms: ? DNA-HIV-PT123 and AIDSVAX® B/E (target wks 0,4,24,48) ? DNA-HIV-PT123 and CN54gp140+MPLA-L (target wks 0,4), then MVA-CMDR and CN54gp140+MPLA-L (target wks 24,48) ? Saline placebo (target wks 0,4,24,48 There was a concurrent 1:1 randomisation comparing two PrEP regimens, open-label: ? Daily TDF/FTC ? Daily TAF/FTC Participants received study PrEP through to 2 weeks after their third immunisation after which access to PrEP reverted to a locally registered supply of generic drug. The trial enrolled at 4 clinical centres, 2 in Tanzania, 1 in South Africa and 1 in Uganda. In total the trial enrolled 1512 participants. At the end of 2024, the trial had closed, all participants have been exited and unblinded and the trial data has been cleaned and the database has been locked. Analysis of the vaccine data has been performed and results have been shared with participants, stakeholders and the media. A manuscript of the vaccine results is currently in preparation. The PrEP analysis has been performed and the manuscript has been written and will be submitted to a peer reviewed journal. |
| Type | Preventative Intervention - Physical/Biological risk modification |
| Current Stage Of Development | Late clinical evaluation |
| Year Development Stage Completed | 2017 |
| Development Status | Closed |
| Clinical Trial? | Yes |
| UKCRN/ISCTN Identifier | NCT04066881 |
| Impact | Trial has closed. No notable impacts |
| Description | Article in Science et Vie |
| Form Of Engagement Activity | A magazine, newsletter or online publication |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | Professor Jonathan Weber discusses the PrEPVacc trial in an Article in Science et Vie (French Magazine)-After 40 years of failure for a vaccine against HIV, How COVID has renewed hope' https://www.science-et-vie.com/corps-et-sante/7-vaccins-prometteurs-dans-les-laboratoires-65320 |
| Year(s) Of Engagement Activity | 2021 |
| Description | Getty photoshoot at the MRC/UVRI Masaka clinical site for the PrEPVacc trial |
| 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 | Media (as a channel to the public) |
| Results and Impact | Luke Dray,a photojournalist for Getty photo agency visited and documented PrEPVacc work at the Masaka site on 16 & 17 March. He photographed trial participants and clinical staff at the site His work can be seen in the Nature Article -Preparing society for an HIV vaccine-16th May 2022 |
| Year(s) Of Engagement Activity | 2022 |
| Description | Key note address |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Professional Practitioners |
| Results and Impact | Professor Jonathan Weber gave a presentation of the PrEPVacc study for the Pride in Stem day which is an International Day of LGBTQIA+ People in STEM. |
| Year(s) Of Engagement Activity | 2021 |
| Description | Media Cafe event in Masaka, Uganda |
| Form Of Engagement Activity | Engagement focused website, blog or social media channel |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Media (as a channel to the public) |
| Results and Impact | A media cafe was hosted by the Health Journalist Network of Uganda to discuss the results of the PrEPVacc trial |
| Year(s) Of Engagement Activity | 2024 |
| URL | https://www.prepvacc.org/news |
| Description | Media cafe |
| 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 | AVAC Media Café - Speakers Eugene Ruzagira (UVRI), Sheila Kansiime (UVRI) provided the briefing and Xoliswa Nomvungu, SAMRC CWG member shared her opinions and response to the study update Link to the AVAC media café recording and password: Link: https://us06web.zoom.us/rec/share/0X_mfb7ueHLEM0pIxCk4zxT3i3PpmYJ6JQlk5ZdGLZxuRe2-RcNKhIsfYz2d2sfI.4pMTs4RuCdsG3YrF Passcode: oRa#.=y1 |
| Year(s) Of Engagement Activity | 2023 |
| URL | https://us06web.zoom.us/rec/share/0X_mfb7ueHLEM0pIxCk4zxT3i3PpmYJ6JQlk5ZdGLZxuRe2-RcNKhIsfYz2d2sfI.4... |
| Description | Media coverage from PrEPVacc results announcement |
| 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 | Media coverage of the results from the PrEPVacc vaccine trial in these news outlets Correio Braziliense: HIV/Aids: Menos pessoas têm a doença, mas mundo está longe da meta The Citizen (Tanzania): HIV vaccine flops in trials Mwananchi (Tanzania) - Majaribio chanjo kuzuia VVU yakosa ufanisi The Microbiologist: HIV vaccines tested in PrEPVacc fail to reduce infections Forbes.com - Despite Gilead's Promising HIV Prevention Drug, A Vaccine Is Still The 'Holy Grail' Monitor (Uganda) - HIV vaccine trial: Experts explain 'false positive' tests News24: Placebo outperformed HIV vaccine tested in SA, Uganda, Tanzania, study results show ScienceBlog: HIV Vaccine Trial Fails to Prevent Infections, Raises New Questions The Heritage Times: Africa's HIV Vaccine Trial Suspended Following Unfavorable Initial Outcomes Le Quotidien du Medecin: Traitement et prévention du VIH : du nouveau sur le PrEPVacc, le cabotégravir et l'abacavir au congrès AIDS 2024 la Repubblica: HIV, fallito il test dei vaccini PrEPVacc Apotheke Adhoc: Aids: HIV-Impfstofftest gescheitert 263chat.com (Zimbabwe): PrEPVacc Study Fails to Demonstrate Efficacy of HIV Experimental Vaccines Precision Vaccinations: HIV Vaccine Candidates Fail to Reduce Infections |
| Year(s) Of Engagement Activity | 2024 |
| URL | http://www.prepvacc.org/news |
| Description | New article by CNN international |
| 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 | A trial is underway that could be 'the last roll of the dice' for an HIV vaccine this decade https://edition.cnn.com/2023/08/28/health/prepvacc-hiv-vaccine-trial-spc-scn-intl/index.html The article by Tom Page resulted from a series of interviews with Jonathan Weber, Eugene Ruzagira, Nishanta Singh and Neetha Morar from the PrEPVacc trial |
| Year(s) Of Engagement Activity | 2023 |
| Description | News article |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | News article on HIV vaccines https://www.prepvacc.org/news/stat-can-the-world-still-invent-an-hiv-vaccine-progress-in-one-area-creates-new-problem |
| Year(s) Of Engagement Activity | 2023 |
| Description | News release |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Professional Practitioners |
| Results and Impact | News Release: African-led PrEPVacc HIV prevention study completes its enrolment https://www.prepvacc.org/news/news-release-african-led-prepvacc-hiv-prevention-study-completes-its-enrolment |
| Year(s) Of Engagement Activity | 2023 |
| Description | Webinar to discuss PrEPVacc trial |
| Form Of Engagement Activity | A formal working group, expert panel or dialogue |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Patients, carers and/or patient groups |
| Results and Impact | A webinar was held by the advocacy group AVAC webinar - Approximately 170 attendees from around the world. Speakers from the PrEPVacc study team, Sheena McCormack (UCL) Eugene Ruzagira (UVRI), Sheila Kansiime (UVRI) and Rachel Kawuma (UVRI). Community opinion on the trial was by presented by Verulam Community working group member Xoliswa. |
| Year(s) Of Engagement Activity | 2024 |
| URL | https://avac.org/event/prepvacc-an-in-depth-look-at-the-trial-and-whats-next |
| Description | Workshop for Uganda Youth Organisations |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Schools |
| Results and Impact | In partnership with trial host communities, we commemorated World HIV Vaccine Awareness Day (18th May) and World AIDS Day (1st December 2023). Engaged communities, mostly the youth, MARPs in HIV prevention discussions, supplied condoms, offered HCT and referral for counselling and PrEP |
| Year(s) Of Engagement Activity | 2023 |
| Description | webinar |
| 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 | AVAC webinar - Approximately 170 attendees from around the world. Speakers Sheena Mc Cormack (UCL), Eugene Ruzagira (UVRI) Sheila Kansiime (UVRI) and Rachel Kawuma (UVRI) Community Opinion by Verulam CWG member Xoliswa Nomvungu discussed the PrEPVacc trial. |
| Year(s) Of Engagement Activity | 2023 |
| URL | https://avac.org/event/prepvacc-an-in-depth-look-at-the-trial-and-whats-next/ |