CAMBRIDGE, Mass.– VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that results from the pivotal Phase 3 study, CONSTANT, of VBI’s prophylactic 3-antigen hepatitis B (HBV) vaccine candidate in adults age 18-45 were published in The Journal of the American Medical Association Network Open. The study was designed to demonstrate manufacturing equivalence of three lots of VBI’s HBV vaccine candidate, as well as to evaluate immunogenicity of VBI’s 3-antigen HBV vaccine candidate compared to a single-antigen HBV vaccine, Engerix-B®, after two and three doses, and safety and reactogenicity. Together with results from the first pivotal Phase 3 study, PROTECT, these results formed the basis for the regulatory submissions of VBI’s 3-antigen HBV vaccine candidate in the U.S., Europe, and Canada.
Dr. Timo Vesikari, M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, principal investigator of the CONSTANT study, and author of the manuscript commented, “In North America and Europe, adults age 25-49 years have the highest rates of HBV infection. Unfortunately, it is also this population who has the lowest adherence rates to the full course of vaccination. The data from this pivotal Phase 3 study have meaningful public health importance, demonstrating the ability of the 3-antigen HBV vaccine candidate to elicit high rates of seroprotection and increased antibody titers after both two and three doses in this population compared to the conventional, single-antigen HBV vaccine. Moreover, these data add to the well-established safety profile of this vaccine.”
Dr. Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer, commented, “We are pleased to have the results of the CONSTANT study published in The Journal of the American Medical Association Network Open. We continue to work with regulatory bodies in North America and Europe to support their review of our marketing authorization applications, as we believe this vaccine candidate has the potential to enhance healthcare providers’ efforts to prevent the spread of HBV infection.”
