Given the urgent need for an preventive Ebola vaccine strategy in the context of the current epidemic, the clinical development plan follows an expedited scheme, aiming at starting a Phase 2B large scale safety and immunogenicity study as soon as possible while assuring the safety of the trial participants.
Phase 1 trials to assess the safety and immunogenicity data of the candidate prime-boost regimen in healthy volunteers are ongoing in the UK, the US and Kenya and Uganda. A further study site has been approved to start in Tanzania. Both prime-boost combinations (Ad26.ZEBOV prime + MVA-BN-Filo boost; and MVA-BN-Filo prime + Ad26.ZEBOV boost) administered at different intervals are being tested in these trials.
Phase 2 trials (this project) are planned to start as soon as the post-prime safety and immunogenicity data from the UK Phase I are available. Phase 2 trials will be conducted in healthy volunteers in Europe (France and UK) and non-epidemic African countries (to be determined). HIV positive adults will also be vaccinated in African countries. The rationale for inclusion of European volunteers in Phase 2, in addition to the trials in Africa, is to allow for higher sensitivity in safety signal detection in populations with low incidence of febrile illnesses, to generate negative control specimens for assay development, to allow for inclusion of health care workers or military personnel that may be deployed to Ebola-endemic regions.
