Preliminary data from the first-in-human phase I study, presented by Janssen in May to a FDA Advisory Committee, indicated that the prime-boost vaccine regimen is immunogenic, regardless of the order of vaccine administration, and only provoked temporary reactions normally expected from vaccination.
The phase II study, to take place in the U.K. and France, is a randomized, placebo-controlled, multicenter trial evaluating the safety, tolerability and immunogenicity of the heterologous prime-boost regimen (Ad26.ZEBOV and MVA-BN-Filo) sponsored by Crucell Holland, one of the Janssen Pharmaceutical Companies.
The study is part of the EBOVAC2 project, a collaborative program involving the University of Oxford, French Institute of Health and Medical Research (Inserm), London School of Hygiene & Tropical Medicine (LSHTM), La Center Muraz (CM), Inserm Transfert (IT) and Janssen. The Innovative Medicines Initiative 2 Joint Undertaking is under grant agreement EBOVAC2 (grant no. 115861), part of the Ebola+ program launched in response to the Ebola virus disease outbreak.
The U.K. study site is led by the Oxford Vaccines Group, part of the University of Oxford, Department of Pediatrics. Additional sites in France will be coordinated by Inserm once all necessary approvals are received. In total, the studies will enroll 612 healthy adult volunteers in U.K. and France, who will be randomized into three cohorts, all receiving the Ad26.ZEBOV prime or placebo on day one and then the MVA-BN-Filo boost or placebo on days 29, 57 or 85.
A second, phase II study in 1,200 volunteers is planned to be initiated in Africa during third quarter of 2015.
