The 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 Tuesday by Janssen at a meeting of the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee as part of discussions on the development and licensure of Ebola vaccines.
“In the study, conducted by the Oxford Vaccines Group, 72 healthy volunteers were randomized into four groups receiving the vaccine regimen or placebo,” Bavarian Nordic stated. “A priming dose of either Ad26.ZEBOV or MVA-BN Filo was administered at day 1 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.”
“Preliminary 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,” the company said in an announcement. “Immune responses post boost appeared to be well balanced with the induction of humoral and cellular immune response components, the latter being comprised of highly polyfunctional CD8+ and CD4+ T cell responses. These results confirm the preclinical results previously reported and warrant further investigation of the vaccine regimen in Phase 2 studies and efficacy trials.”
Bavarian Nordic President and Chief Executive Officer Paul Chaplin said, "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. We are pleased to continue our collaboration with Janssen, which is demonstrating leadership by continuing its efforts to improve the manufacturing capabilities, establishing the necessary infrastructure and developing strategies for deployment of vaccines for the current and future outbreaks in Africa."
Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, is sponsoring additional Phase 1 clinical studies of the prime-boost vaccine regimen, currently ongoing in the US and non-affected African countries, and is working closely with health authorities in the planning of efficacy trials in Sierra Leone.
Bavarian Nordic is manufacturing MVA-BN Filo under an agreement with Crucell Holland B.V. and has now delivered 500,000 doses of the vaccine. The company remains on track to complete deliveries of a total of approximately 2 million doses by the end of first half 2015.