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 combination HIV vaccine + pre-exposure prophylaxis (PrEP) phase IIb study using an innovative adaptive trial design. PrEPVacc is exploiting >20 years of European HIV research to demonstrate the efficacy of two regimens of experimental DNA, MVA and Env protein/adjuvant vaccines. All these PrEPVacc GMP vaccine products have already been studied in Europe and Africa in >600 volunteers, and are safe and immunogenic. This proposal is based on prior FP5, FP7, H2020 and EDCTP-1 programmes and will leverage substantial co-funding support from IAVI, CAVD, UK MRC, Wellcome Trust and Gilead. PrEPVacc represents a consortium of highly experienced African investigators, with access to high-risk populations and accredited laboratories in Uganda, Tanzania, Mozambique and South Africa, together with broad research capacity building. PrEPVacc is an African study; the trial database, trial management, all primary laboratory assays and data analyses will be undertaken by the PIs, coordinated through MRC/UVRI, Entebbe, with technical support and capacity building from IAVI, CHUV, Imperial, LMU, KI and MRC/CTU. The adaptive trial design is novel in the HIV vaccine field; we shall generate data on HIV vaccine efficacy and investigate correlates of protection, address adherence and attitudes to PrEP and its impact on HIV vaccine trials. The results of PrEPVacc will potentially have great impact: by testing a DNA-MVA immunisation regime with more potent T-cell and similar B-cell immunogenicity compared to the RV144 trial, the only HIV vaccine trial to have shown protective efficacy; by comparing DNA-MVA-protein with DNA-protein immunisation; by exploring universal PrEP in an HIV vaccine study population for the first time. If PrEPVacc is successful, we will have delivered a biomedical intervention to reduce HIV incidence which could be generalised and commercialised; if these vaccines fail, a new generation of candidates may be required. PrEPVacc fits EDCTP2 vaccine objectives; a combination vaccine/PrEP approach to prevent HIV infection would have a major public health impact. The proposal is highly efficient; a novel design will allow early cessation of futile arms. The proposal is timely: phase 1&2 trials of these products have recently demonstrated safety and immunogenicity in Europe and Africa. PrEPVacc is complementary and scientifically additive to the HVTN 702 pox/protein phase 3 trial, with added potential for generating new data on B- and T-cell immunogenicity after different DNA priming strategies and the impact of PrEP on vaccine trials. PrEPVacc will strengthen South-South and South-North collaboration and promote African self-sufficiency for future trials.
Website visit project website
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
2 Uganda National Health Research Organisation Partner Uganda
3 Karolinska Institutet Partner Sweden
4 Ludwig-Maximilians-Universitaet Muenchen Partner Germany
5 Muhimbili University of Health & Allied Sciences Partner Tanzania, United Republic of
6 National Institute for Medical Research - Tanzania Partner Tanzania, United Republic of
7 Instituto Nacional de Saúde Partner Mozambique
8 South African Medical Research Council Partner South Africa
9 Centre Hospitalier Universitaire Vaudois Partner Switzerland
10 KwaZulu-Natal Research Institute for TB-HIV Partner South Africa
11 University College London Partner United Kingdom
12 EuroVacc Foundation Partner Switzerland
13 International AIDS Vaccine Initiative Inc Partner United States