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hepatitis B vaccine (recombinant, 3-antigen)
- Development stage
- Approved
- Lead developer
- VBI Vaccines
- Modality
- Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
- Administration
- Intramuscular
01
Overview
Hepatitis B vaccine (recombinant, 3-antigen) is a trivalent recombinant biologic vaccine containing the three hepatitis B surface antigens: S, pre-S1, and pre-S2. Developed by VBI Vaccines, it was designed to provide a more robust immune response compared to traditional single-antigen (S-only) vaccines. It received FDA approval in 2021 (as PreHevbrio) and subsequent approvals in the EU, UK, and Canada in 2022 for the prevention of hepatitis B virus (HBV) and hepatitis D virus (HDV) infection in adults. The vaccine is produced in a mammalian cell line (CHO), which allows for the inclusion of the pre-S1 and pre-S2 components. In November 2024, the manufacturer initiated a voluntary recall and discontinued the product due to company restructuring and discontinuation of operations.
- Brand names
- PreHevbrioPreHevbriSci-B-Vac
- Other names
- 3-antigen hepatitis B vaccinetrivalent hepatitis B vaccinerecombinant hepatitis B vaccine (S, pre-S1, pre-S2)
02
Targets
HBsAg (Hepatitis B surface antigen)
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