Project: The Partnership for Research on Ebola Vaccinations-extended follow-UP and clinical research capacity build-UP
| Acronym | PREVAC-UP (Reference Number: RIA2017S-2014) |
| Duration | 01/01/2019 - 30/06/2024 |
| Project Topic | Human-to-human transmission of Ebola virus in West Africa was interrupted in 2016 but the risk of reemergence of the disease is real. Thus, efforts to develop a safe and effective vaccine against Ebola virus disease with a durable prophylactic effect in communities must continue. The Partnership for Research on Ebola Vaccinations (PREVAC) is an international consortium including the French Institute of Health and Medical Research, the London School of Hygiene & Tropical Medicine, the US National Institutes of Health, health authorities and scientists from Guinea, Liberia, Mali and Sierra Leone, a non-governmental organisation (Alliance for International Medical Action), and Merck, Johnson & Johnson and Bavarian Nordic companies. The PREVAC trial is a phase IIB, randomised, placebo controlled, multicentre trial evaluating the safety and immunogenicity over 12 months of three vaccine strategies in children and adults. Participants are randomised to one of five groups: (i) vaccination with Ad26.ZEBOV prime and MVA-BN-Filo boost, (ii) vaccination with rVSVΔG-ZEBOV-GP prime and a boost of the same vaccine, (iii) vaccination with rVSVΔG-ZEBOV-GP vaccine without boost, (iv) placebo group 1 and (v) placebo group 2. Preliminary phases started in Liberia and Guinea in March 2017; the main phase of the trial evaluating the five regimens will begin in Liberia, Guinea Sierra Leone and Mali in April 2018 with an enrolment targets of 1,400 adults and 1,400 children. The research proposal PREVAC-UP is built around the PREVAC consortium. Its two primary objectives are to determine (i) the long-term immunogenicity and safety and (ii) durability of humoral and cellular immune responses of Ebola vaccine regimes over 60 months. We will also evaluate the effect of co-infections, such as malaria and helminths on the immune response to vaccination. An integrative statistical analysis of the immune response will be used to explore the mechanism of action of the vaccines and to identify early correlates of durable antibody induction. We will also build on the extensive community mobilisation efforts previously generated through PREVAC to provide a trans-national platform for social and health science research and training. Finally, this research proposal will expand and sustain capacity building and training of scientists in the four participant African countries. This programme is expected to significantly impact Ebola prevention and control in adults and children in Africa. The proposed study will also strengthen capacity for science relevant to the development and evaluation of new vaccines in sub-Saharan Africa. |
| Network | EDCTP2 |
| Call | Strategic actions supporting large-scale clinical trials 2017 |
Project partner
| Number | Name | Role | Country |
|---|---|---|---|
| 1 | l'Institut national de la santé et de la recherche médicale | Coordinator | France |
| 2 | Centre National de Formation et de Recherche en Santé Rurale | Partner | Guinea, Republic of |
| 3 | College of Medicine and Allied Health Sciences, University of Sierra Leone | Partner | Sierra Leone |
| 4 | Inserm-Transfert SA | Partner | France |
| 5 | Institut Bouisson Bertrand | Partner | France |
| 6 | London School of Hygiene and Tropical Medicine | Partner | United Kingdom |
| 8 | Ministry of Health - Mali | Partner | Mali |
| 9 | The Alliance for International Medical Action | Partner | France |
| 12 | Université des Sciences, des Techniques et des Technologies de Bamako | Partner | Mali |