Bavarian Nordic has announced that 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 the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The first volunteers have received their initial vaccine dose.
Preliminary data from the first-in-human Phase I 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 Phase II study, to take place in the UK and France, is a randomized, placebo-controlled, multicenter trial evaluating the safety, tolerability and immunogenicity of the heterologous prime-boost regimen (Ad26.ZEBOV and MVA-BN-Filo) sponsored by Crucell Holland, one of the Janssen Pharmaceutical Companies.
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 (LSHTM), La Centre Muraz (CM), Inserm Transfert (IT) and Janssen. The Innovative Medicines Initiative 2 Joint Undertaking is under grant agreement EBOVAC2 (grant no. 115861), part of the Ebola+ program launched in response to the Ebola virus disease outbreak.
The UK study site is led by the Oxford Vaccines Group, part of the University of Oxford, Department of Paediatrics. Additional sites in France will be coordinated by Inserm once all necessary approvals are received. In total, the studies will enroll 612 healthy adult volunteers in UK and France, who will be randomized into three cohorts, all receiving the Ad26.ZEBOV prime or placebo on day 1 and then the MVA-BN-Filo boost or placebo on days 29, 57 or 85.
A second Phase II study in 1200 volunteers is planned to be initiated in Africa during third quarter of 2015.
Paul Chaplin, President & CEO of Bavarian Nordic, said: "We are pleased to report further progress in the clinical development of the prime-boost Ebola vaccine regimen which is being led by our partner Janssen. 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."
This Innovative Medicines Initiative 2 Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.
