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Publication of results from pivotal phase III study, PROTECT, of VBI’s prophylactic 3-antigen hepatitis B vaccine candidate.

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Published:2nd Dec 2021
VBI Vaccines Inc. announced that the FDA has approved PreHevbrio [Hepatitis B Vaccine (Recombinant)] for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older.

PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.S.

The approval of PreHevbrio was based on the results from two Phase III clinical studies, PROTECT and CONSTANT, data from which were published, respectively, in The Lancet Infectious Diseases in May 2021 and The Journal of the American Medical Association Network Open in October 2021.

The pivotal studies compared PreHevbrio to Engerix-B, a single-antigen HBV vaccine. Data from the PROTECT study showed that PreHevbrio elicited higher rates of seroprotection in all subjects age 18+ (91.4% vs. 76.5%), including in adults age 45+ (89.4% vs. 73.1%). The integrated safety analysis of both studies demonstrated good tolerability with no unexpected reactogenicity. The most common adverse events in all age groups were injection site pain and tenderness, myalgia, and fatigue, all which generally resolved without intervention in 1-2 days.

VBI expects to make PreHevbrio available in the U.S. in the first quarter of 2022, and has partnered with Syneos Health for the past two years to ensure commercial readiness.

See- VOLUME 21, ISSUE 9, P1197-1198, SEPTEMBER 01, 2021. "Three are better than one—increasing HBV seroprotection by a tri-antigenic vaccine":Florian van Bömmel, Thomas Berg. Published:May 11, 2021DOI: The Lancet Infectious Diseases.

See- "Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs a Single-Antigen Hepatitis B Vaccine. A Phase III Randomized Clinical Trial": Timo Vesikari, MD; Francisco Diaz-Mitoma, MD, PhD; for the CONSTANT Study Group; JAMA Net Open. 2021;4(10):e2128652. doi:10.1001/jamanetworkopen.2021.28652.

Condition: Hepatitis B
Type: drug

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