Bavarian Nordic A/S recently announced that the first subject has been dosed with MVA-BN Filo in a Phase 1 safety and immunogenicity trial, evaluating a heterologous prime-boost regimen of Ebola candidate vaccines.
The trial, sponsored by the University of Oxford, is assessing the monovalent cAd3-EBO Z vaccine co-developed by GSK and the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and Bavarian Nordic’s multivalent MVA-BN Filo vaccine, designed to protect against Ebola Zaire, Ebola Sudan and Marburg virus.
Recent preclinical research has shown that by employing an MVA-based booster dose, the vaccine may offer a more robust and durable immune response. The investigators hope to be able to replicate these findings in clinical studies and have therefore chosen to include Bavarian Nordic’s MVA-BN Filo vaccine in the study for a heterologous boost.
The study is enrolling 60 healthy adults in three cohorts receiving different doses of the cAd3-EBO Z vaccine. Half of the subjects in each cohort will furthermore receive a booster dose of the MVA-BN Filo vaccine. Primary objective is the assessment of safety and tolerability; secondary objective is the assessment of cellular and humoral immune responses. Preliminary results from the study are anticipated in the first half of 2015.
Both the cAd3-EBO Z vaccine and the MVA-BN Filo vaccine have been developed in collaboration with NIAID. In partnership with Bavarian Nordic and Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, NIAID furthermore investigated a prime-boost regimen of Bavarian Nordic’s MVA-BN Filo and Janssen’s AdVac® technology. Based on promising preclinical results, Bavarian Nordic and Janssen recently entered into a collaboration to develop and manufacture large quantities of this vaccine regimen, which is planned to enter clinical trials shortly.
“In support of the various clinical trials currently underway to fast-track the development of urgently needed vaccines against Ebola, we are pleased that these studies may confirm the role of a heterologous prime boost regimen incorporating the MVA-BN vaccine platform technology,“ said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. “We are also making progress in our collaboration with Janssen as part of their commitment to accelerate and expand the production of its Ebola vaccine regimen. Manufacturing of our MVA-BN Filo vaccine is well underway and the first trial in humans of this prime-boost vaccine regimen will soon open for enrollment.”