Bavarian Nordic A/S this week announced the initiation of a new clinical study of the Ebola prime-boost vaccine regimen that combines Bavarian Nordic’s MVA-BN® Filo vaccine with the Ad26.ZEBOV vaccine from Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
The ‘EBOVAC-Salone’ study is being conducted in Sierra Leone’s Kambia district, where some of the country’s most recent Ebola cases have been reported. The first volunteers have received their initial vaccine dose.
The study, coordinated by the London School of Hygiene & Tropical Medicine and sponsored by Janssen, is designed to evaluate the safety and immunogenicity of the combination regimen.
Volunteers will first be given the Ad26.ZEBOV dose to prime their immune system, and then the MVA-BN Filo dose at a later date to boost their immune response, with the goal of creating stronger and longer-lasting immunity.
The first stage of the study, which has now been initiated, includes approximately 40 adults aged 18 years or older. In stage 2, approximately 400 individuals across different age groups will be vaccinated, including children and adolescents. Additional stages are being finalized in consultation with the Sierra Leonean authorities and international health agencies.
“The key attributes of both the MVA-BN and Ad26 technologies were initially recognized through NIH funding and subsequently the program has benefited from additional governmental funding,” said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic. “We believe our progress to date highlights the potential for a successful model of private-public partnerships in the development of products addressing unmet medical needs for the future.”
The EBOVAC-Salone study is being initiated on a parallel track with multiple ongoing Phase 1 and 2 studies that are being conducted across the U.S., Europe and Africa as part of the accelerated development plan for the Ebola vaccine regimen. First-in-human Phase 1 clinical studies of the prime-boost vaccine regimen began in the United Kingdom and United States in January 2015, followed by several sites in Africa.
In May 2015, Janssen presented positive preliminary data from the UK Phase 1 study to the U.S. Food and Drug Administration. A Phase 2 study, being carried out in the UK and France, started in July 2015 with a second multi-site Phase 2 study planned to shortly commence in several West and East African countries.
MVA-BN Filo is developed using Bavarian Nordic’s proprietary vaccine platform technology, MVA-BN, which is also employed in the company’s smallpox vaccine, IMVAMUNE (approved in EU and Canada under the trade name IMVANEX). To-date, Bavarian Nordic has produced and delivered 28 million doses of the smallpox vaccine for emergency use to the U.S. Strategic National Stockpile.
Source: Bavarian Nordic press release, adapted.
