Rodolphe Thiebaut,deputy director oh the research center U897 and director of the team SISTM, is the coordinator of the EBOVAC2 project, which launches its recruiting campain on the 8th of december.
The project, a collaborative effort, funded under a grant from the Innovative Medicines Initiative Ebola+ programme. EBOVAC2 was launched in response to the Ebola virus disease outbreak, to assess the safety and immunogenicity of a novel ‘prime-boost’ preventative vaccine regimen against Ebola Virus Disease (EVD). In France, clinical research centres specialised in vaccination are now recruiting approximately 300 healthy volunteers from 18 to 65 years old. The project is coordinated by Inserm.
The objectives of the EBOVAC2 studies are to further determine the vaccine regimen’s safety profile and how well it stimulates the immune system to protect against Ebola infection.
Two vaccines will be given a few weeks apart. The first dose is intended to stimulate, or ‘prime’, an initial immune response. The second dose then is designed to ‘boost’ the level of the body’s immune response further.
Researchers also want to work out the best timing for each of the vaccine doses. Volunteers will be put on different schedules, where the gap between ‘prime’ and ‘boost’ dose will be 28, 56 or 84 days. This strategy offers the advantage of potentially leading to improved and, especially, longer lasting immunity.
“The volunteers are divided into three groups. Participants in this trial cannot become infected with the Ebola virus. Only synthetic proteins or parts of proteins are used in the various vaccines being tested. They cannot in any way cause infection. This is based on the same principle as many existing vaccines for infectious diseases,” explains Professor Rodolphe Thiébaut, coordinator of the Ebovac2 Project.
How is the vaccine trial for the Ebovac2 project organized?
Commencement of the Ebovac2 Phase 2 trials has been subject to the preliminary results from several ongoing phase 1 trials being carried out in Africa, the United Kingdom, and the United States, which show that the vaccine regimen is well-tolerated.
As part of the Ebovac2 Phase 2 studies, one trial (EBL2001) will be carried out in France and the United Kingdom (Oxford University) with a total of 630 volunteers, about 300 of whom will be in France. A second trial (EBL2002) will be conducted in several countries in Africa with a total of 1188 volunteers expected to be recruited. Volunteers are expected to participate in the trial for 1 year. Each volunteer will be rigorously monitored, and will be personally followed up by a doctor involved in conducting the study. Volunteers will be visited between 9 and 15 times, and will receive either the vaccine or a placebo. They are entirely free to interrupt their participation at any time and will be reimbursed for their time.
The vaccine trial has received all necessary authorisations guaranteeing the safety of volunteers (approval from the Comité de Protection des Personnes de Ile de France III, an institutional review board, as well as approval from the Agence Nationale de Sécurité du Médicament et des Produits de Santé, or French Agency for the Safety of Health Products).