EBOVAC3
EBOVAC3 project: Open-label, Randomized, Clinical Trial to Evaluate the Immunogenicity and Safety of a Prophylactic Vaccination of Health Care Providers by Administration of a Heterologous Vaccine Regimen Against Ebola in the Democratic Republic of the Congo
This open-label, single-centre, randomised phase 2 vaccine trial was performed in Boende, Democratic Republic of the Congo, with health care providers and frontliners as trial participants, as they are more at risk of contracting and spreading the Ebola virus disease. The primary and a secondary outcome of this trial was to evaluate the immunogenicity and safety of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen, administered at a 56-day interval. Overall, vaccine regimen and booster dose were well-tolerated and led to a durable immune response in study participants, supporting the use of the regimen and booster dose for prophylactic vaccination of at risk populations.
Overview of partnerships/ongoing research:
EBOVAC3 'in-house' team members
EBOVAC3 - General project information (click to open expansion pannel to read more)
Summary
The EBOVAC3 project aims to assess, through clinical trials in children and adults in Africa, the safety and effectiveness of an Ebola vaccine regimen. As such it will help to improve the world’s preparedness to deal with an Ebola outbreak. The project focuses on the ‘prime-boost’ Ebola vaccine regimen (Ad26.ZEBOV and MVA-BN-Filo) prime-boost’ Ebola vaccine regimen, in which patients are first given a dose to prime the immune system, and then a boost dose which is intended to enhance the immune response over time. Building on work carried out under the EBOVAC1 and 2 projects, EBOVAC3 will run clinical trials in children in Sierra Leone, Guinea and the Democratic Republic of Congo. It will also follow up people who participated in earlier clinical trials in Sierra Leone, to assess the safety and efficacy of the vaccine in the longer term. Finally, the project aims to characterize the outbreak preparedness of Sierra Leone, Guinea and the Democratic Republic of Congo.
Funding
The EBOVAC3 project has received funding from the IMI2 Joint Undertaking. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme, European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Coalition for Epidemic Preparedness Innovations (CEPI). For this trial, the Contract Research Organisation and part of the FANG ELISA analyses are funded by the CEPI. All other trial activities are funded by the IMI2 Joint Undertaking grant. All vaccines and neutralizing antibody level analyses against Ad26 at the first visit are provided by Janssen Vaccines & Prevention B.V. .
Partner(s)
- University of Kinshasa, Janssen Vaccines & Prevention B.V., ACE Research and DFNet Research
- External partners: The London School of Hygiene and Tropical Medicine (LSHTM), the Institut National de la Santé et de la Recherche Médicale (INSERM), and the College of Medicine and Allied Health Sciences (COMAHS)
Period
01/06/2018 - 30/09/2024
more information on EBOVAC3 website and IMI project portal
