• First study of the Ad26.ZEBOV/MVA-BN® Filo prime-boost vaccination regimen in an Ebola outbreak country
• Study being initiated on parallel track with multiple ongoing Phase 1 and 2 studies across U.S., Europe and Africa to support licensure of the vaccine regimen
COPENHAGEN, Denmark, October 9, 2015 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today 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 (Janssen). The study called ‘EBOVAC-Salone’ 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. Further details of the study can be found at http://clinicaltrials.gov/ct2/show/NCT02509494.
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said: “The initiation of EBOVAC-Salone marks an important milestone for our joint program with Janssen. It is a significant step forward in the development of a vaccine against Ebola. It is remarkable how far the program has moved, which has only been possible due to the commitment and dedication shown by both Janssen and our employees in terms of the progress we have made in manufacturing bulk vaccine for almost 2 million doses and initiating this study within a year of joining forces. 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. 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.
With nearly 14,000 people infected by Ebola, Sierra Leone accounts for the largest number of cases in any of the West African countries affected by the outbreak that has raged since 2014. In total, more than 28,000 people have been infected with the virus in the region and more than 11,000 people have died. Although only few new cases have been reported over the past months, Sierra Leone along with Guinea remains yet to be declared Ebola-free.
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