Ebola vaccine phase two trial begins
An international biotech company has announced the start of a phase two clinical study of a vaccine to help fight Ebola.
The prime-boost vaccine regimen combines Bavarian Nordic’s MVA-BN® Filo vaccine with the Ad26.ZEBOV vaccine from the Janssen Pharmaceutical Companies of Johnson & Johnson. The study will be carried out by the Oxford Vaccines Group, part of the UK’s University of Oxford, in the UK and France. The study is a randomised, placebo-controlled, multicentre trial evaluating the safety, tolerability and immunogenicity of the heterologous prime-boost regimen. In total, the studies will enrol 612 healthy adult volunteers.
The study is part of the EBOVAC2 project, a collaborative programme involving multiple European partners and funded by the Innovative Medicines Initiative 2 Joint Undertaking, part of the Ebola+ programme launched in response to the Ebola virus disease outbreak.
Paul Chaplin, president and chief executive of Bavarian Nordic, which is based in Denmark, said: “Vaccines play an essential role in outbreak situations, and both the clinical and the manufacturing experience we gain through this accelerated development represent an important piece of work in the combined efforts to ensure preparedness against Ebola, now and in the future.”
Preliminary data from the first-in-human phase one study, presented by Janssen in May to a US Food & Drug Administration 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 first volunteers in phase two have received their initial vaccine dose; a second phase two study involving 1,200 volunteers is planned to be initiated in Africa during third quarter of 2015.
