Oxford Vaccine Group initiates Phase 2 study of Ebola prime-boost vaccine regimen combining MVA-BN-Filo and Ad26.ZEBOV
Posted: 15 July 2015 |
Oxford Vaccine Group has initiated a Phase 2 clinical study of the Ebola prime-boost vaccine regimen that combines MVA-BN-Filo with Ad26.ZEBOV…
The first volunteers have received their initial vaccine dose.
Preliminary data from the first-in-human Phase 1 study 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 2 study, to take place in the UK and France, is a randomised, placebo-controlled, multicentre trial evaluating the safety, tolerability and immunogenicity of the heterologous prime-boost regimen (Ad26.ZEBOV and MVA-BN-Filo).
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 United Kingdom and France, who will be randomised 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 2 study in 1,200 volunteers is planned to be initiated in Africa during third quarter of 2015.
MVA-BN-Filo and Ad26.ZEBOV regimen resulted in complete protection from death due to Ebola in preclinical studies
Paul Chaplin, President & Chief Executive Officer 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.”
MVA-BN Filo is a multivalent vaccine candidate designed to protect against Ebola Zaire, Ebola Sudan and Marburg viruses.
Preclinical studies conducted by the NIH of a prime-boost vaccination regimen consisting of MVA-BN Filo and Janssen’s Ad26.ZEBOV vaccine resulted in complete protection from death due to Ebola was achieved against the Kikwit Zaire strain, which is similar to the virus that is the cause of the current epidemic in West Africa. Each of the vaccine components is a proven technology that has previously been evaluated for immunogenicity and safety when used in humans for other applications.