The Oxford Vaccines Group has initiated a Phase II clinical study of the Ebola prime-boost vaccine regimen that combines Bavarian Nordic’s MVA-BN Filo vaccine with the Ad26.ZEBOV vaccine from Janssen, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ).
The first volunteers have been given their initial vaccine dose. Early data from the first in-human Phase I study, presented by Janssen in May to an advisory committee of the US Food and Drug Administration, indicated that the prime-boost vaccine regimen is immunogenic, regardless of the order of vaccine administration, and any reactions provoked were temporary and normally expected from vaccination.
The Phase II study, which will take place in the UK and France, is a randomized, placebo-controlled, multicenter trial to evaluate the safety, tolerability and immunogenicity of the heterologous prime-boost regimen sponsored by Crucell Holland, one of the Janssen Pharmaceutical Companies.
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