Tri-Antigenic Hepatitis B Vaccine Candidate Found Immunogenic and Safe

Massachusetts-based VBI Vaccines Inc. announced today The Lancet published results from the pivotal Phase 3 study, PROTECT, of the company's prophylactic 3-antigen hepatitis B (HBV) vaccine candidate (Sci-B-Vac) in adults.

The study was designed to compare the immunogenicity and safety of 10 µg of VBI’s 3-antigen vaccine candidate to 20 µg of the single-antigen HBV vaccine, Engerix-B®.

'Regardless of age, BMI, or diabetic status, participants who received the Sci-B-Vac vaccine candidate achieved higher seroprotection rates, and 5-8x higher antibody geometric mean concentration (GMC) compared to Engerix-B®. And, no safety signals were observed.'

Together with results from the second pivotal Phase 3 study, CONSTANT, these results form the basis for the regulatory submissions of VBI’s 3-antigen HBV vaccine candidate in the U.S. and Europe, which were submitted in November 2020, and for Canada and the U.K., which are in process, said the company.

Timo Vesikari, M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, principal investigator of the PROTECT and CONSTANT Phase 3 clinical studies, and author of the manuscript commented in a press statement, “While HBV immunization programs effectively address infants, large immunization gaps exist in certain adult populations, due in large part to the poor immune response in many risk groups such as older adults, people with diabetes or kidney disease, overweight adults, and those who smoke."

"The PROTECT study demonstrated that the 3-antigen hepatitis B vaccine may be able to overcome some of the limitations of conventional single-antigen HBV vaccines in adults, particularly in older adults age 45+ where superior immune responses were achieved.”

The Lancet's Interpretation of the VBI funded study was: 'The safety and efficacy of the tri-antigenic hepatitis B vaccine show its usefulness for the prevention of HBV infection in adults, including those with stable and controlled chronic conditions.'

VBI Vaccines Inc. is an international biopharmaceutical company driven by immunology to pursue powerful prevention and treatment of disease.