Project: Weber A combination efficacy study in Africa of two DNA-MVA- or DNA- Env protein HIV-1 vaccine regimens with pre-exposure prophylaxis (PrEP)

Acronym PrEPVacc (Reference Number: RIA2016V-1644)
Duration 01/01/2018 - 31/03/2023
Project Topic PrEPVacc is 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. The trial will take place at 5 clinical research centres located  in 4 countries (Durban, South Africa; Maputo, Mozambique; Mbeya and Dar es Salaam, Tanzania; Masaka, Uganda) in Africa and aims to recruit 1668 participants (556 participants/arm) from high risk populations. This is a highly collaborative, multi-disciplinary project, co-ordinated by Imperial College with 13 beneficiaries from Africa, Europe, and the US, all of whom have extensive experience in HIV vaccine and/or prevention trials.  PrEPVacc is an African study, with the trial database, trial management and co-ordination carried out at the MRC/UVRI (UNHRO)Uganda Research Unit, supported by MRC CTU at UCL. In the first reporting year, one of the main objectives of the project was to set up a feasibility study (registration cohort study) at all the clinical sites to identify, recruit, and follow-up a cohort of adult HIV-negative volunteers likely to have  high rates  of HIV infection to more accurately determine the incidence, and facilitate a timely enrolment of cohort participants eligible for the vaccine trial. During this year, the study protocol and study documents were developed by the PrEPvacc clinical teams for in country ethics submissions and all sites received national and local ethics approval to enroll participants into the registration cohort.  By the end of 2018, 4 out of 5 centres had successfully screened and enroled participants into this study. Although the studies are independent, they utilize a common database established by MRC/UVRI (UNHRO)Uganda Research Unit. Preparations for the vaccine trial also began in the first reporting period, and the vaccine trial protocol was written and approved by the research ethics committee of the project sponsor. Capacity building has been well established during this reporting period. Two clinicans from Tanzania have registered for PhD programmes funded by the Swedish government and are evaluating HIV vaccines in high risk populations in Tanzania.  Knowledge transfer and expertise from PrEPVacc partners has been provided to the clinical centres in order to facilitate the development of both current and future clinical and research capacity.  
Network EDCTP2
Call Vaccines for poverty-related diseases (PRDs)

Project partner

Number Name Role Country
1 Imperial College of Science Technology and Medicine Coordinator United Kingdom
4 Centre Hospitalier Universitaire Vaudois Partner Switzerland
7 Eastern Virginia Medical School Partner United States
8 EuroVacc Foundation Partner Switzerland
11 Instituto Nacional de Saúde Partner Mozambique
15 International AIDS Vaccine Initiative Inc Partner United States
16 Karolinska Institutet Partner Sweden
19 KwaZulu-Natal Research Institute for TB-HIV Partner South Africa
23 Ludwig-Maximilians-Universitaet Muenchen Partner Germany
27 Muhimbili University of Health & Allied Sciences Partner Tanzania
31 National Institute for Medical Research - Tanzania Partner Tanzania
35 South African Medical Research Council Partner South Africa
39 Uganda National Health Research Organisation Partner Uganda
43 University College London Partner United Kingdom