Preliminary results from a Phase 1 first-in-human study of the Ebola prime-boost vaccine regimen of Bavarian Nordic’s MVA-BN® Filo vaccine and the AdVac® vaccine from the Janssen Pharmaceutical Companies of Johnson & Johnson were presented by Janssen at a meeting of the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee. The presentation was part of discussions on the development and licensure of Ebola vaccines.
In the study, conducted by the Oxford Vaccines Group, 72 healthy volunteers were randomly placed into four groups receiving the vaccine regimen or placebo. A priming dose of either Ad26.ZEBOV or MVA-BN Filo was administered on the first day and booster doses of the other vaccine were administered after 28 or 56 days. An open label arm with 15 healthy volunteers is also investigating a shorter prime-boost interval of 14 days for Ad26.ZEBOV prime and MVA-BN Filo boost, according to BioSpace.com.
Early data from this ongoing study shows that the prime-boost vaccine regimen “was immunogenic, regardless of the order of vaccine administration, and that both vaccines only provoked temporary reactions normally expected from vaccination,” a BioSpace.com article noted. These and other results support the previously-reported preclinical results and call for further investigation of the vaccine regimen in Phase 2 studies and efficacy trials.
Bavarian Nordic President & Chief Executive Officer Paul Chaplin, says, “These preliminary Phase 1 results are encouraging as they confirm the ability of MVA-BN to boost the immune response, which is crucial for obtaining long-term protection and designing a suitable vaccination strategy for future outbreaks.”
Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, is sponsoring additional Phase 1 clinical studies of the prime-boost vaccine regimen, in the U.S. and non-affected African countries, and is working closely with health authorities in the planning of efficacy trials in Sierra Leone.