The main objective of EBOVAC2 is to provide extensive and robust data on the safety and immunogenicity of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen.
This will be done by:
- Carrying out translational studies to link vaccine elicited immune responses in humans to protection from Ebola in vaccinated non-human primates;
- Carrying out Phase 2 trials in African and European volunteers. Given the compressed nature of this development program, the Phase 2 studies are anticipated to be conducted in parallel with the planned Phase 3 study (EBOVAC1). The EBOVAC2 Phase 2 studies will be controlled with either placebo or active control vaccinations with standard vaccines and will be conducted in locations where it is possible to perform carefully controlled safety studies;
- Evaluating the use of the vaccine regimen in healthy population groups, such as children (aged 1-17 years), the elderly (ages 50-65) and individuals infected with HIV, to confirm safety and immunogenicity. It is intended that Phase 2 trials will begin as soon as preliminary safety data are available from Phase 1 trials;
- Monitoring and characterising immune response to the proposed vaccine regimen;
- Boosting the capacity of African centres and staff as well as communicating and disseminating the results of EBOVAC2 as they become available to all key stakeholders;
- Contributing all data to the Central Information Repository (set up in EBOVAC1) for use by all Ebola+ projects as well as the wider community.
© Janssen
