A Phase II clinical study* of an Ebola vaccine regimen being developed by Janssen and Bavarian Nordic has kicked off with healthy volunteers in England and France.
The first arm of the trial will test the safety, tolerability and immunogenicity of the heterologous prime-boost regimen - which combines Bavarian Nordic’s MVA-BN Filo vaccine with Janssen's Ad26.ZEBOV - in 612 healthy adults volunteers.
A second Phase II study in 1,200 volunteers is planned to start in Africa during third quarter of 2015.
The move to Phase II follows preliminary data from the first-in-human Phase I study indicating that the regimen is immunogenic, regardless of the order of vaccine administration, and only provoked temporary reactions normally expected from vaccination, the groups noted.
While the number of Ebola cases in the recent West African outbreak - which claimed near 5,000 lives - has plummeted, there are growing fears over a resurgence of the deadly virus, for which there remains no approved vaccine or cure.
Liberia had been declared Ebola free earlier this year, but just hours ago authorities confirmed a second death from the disease, underscoring the urgent need for an effective weapon to contain its spread.
*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, La Centre Muraz, Inserm Transfert and Janssen.