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HBV Vaccine

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Vaccine

Hepatitis B Virus (HBV) Vaccine

Hepatitis B is an infectious disease of the liver due to the hepatitis B virus (HBV). Chronic infections can be caused by Hepatitis B and expose people to a high risk of dying from cirrhosis and liver cancer. Several HBV vaccines are available on the market to prevent potentially fatal hepatitis B disease, providing 98%-100% protection.

Based on the efforts of Bulmberg who discovered the Australian Antigen and was awarded the Noble Prize, the first generation of HBV vaccines was approved in 1981. The Australian Antigen, referred to as hepatitis B surface antigen (HBsAg) now, was found and purified in the sera of HBV-infected patients. The distinctive vaccine was developed by directly obtaining HBsAg from human carriers.

However, the blood-derived vaccine was replaced in 1986 by modified recombinant HBsAg (like Recombivax HB, Engerix-B) produced using recombinant DNA methods and in yeast cells out of biosafety concerns.

The manufacturing of existing yeast-derived HBV vaccines is based on the self-assembly of HBsAg monomers into VLPs. Purified HBsAg has been reported to present VLPs of ∼22 nm. And 60% to 70% of the formed HBsAg VLPs consist of HBsAg monomeric proteins, with the remainder containing lipids. In summary, the generated VLPs exhibit a heightened immunogenicity, proficiently inducing robust neutralizing antibodies. This vaccine stands out for its safety profile, as it is devoid of any viral genome.

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Fig 1. Electron micrograph of recombinant hepatitis B virus surface antigen (HBsAg). Website: FEMS Microbiology Letters.

Yaohai Bio-Pharma offers One-Stop CDMO Solution for HBV VLP Vaccine
HBV VLP Vaccines Pipelines

Generic Name

Brand Name/ Alternative Name

Expression System

Originator/Manufacture

R&D Stage

Hepatitis B vaccine, recombinant

Recombivax HB, Heptavax-II

Yeast (Saccharomyces cerevisiae)

Merck

Approval

Hepatitis B vaccine, recombinant

Engerix-B

Yeast (Saccharomyces cerevisiae)

GlaxoSmithKline

Approval

Adjuvanted Hepatitis B vaccine (Recombinant)

V270, V-270, HBsAg-1018, HEPLISAV-B, HEPLISAV

Yeast (Hansenula polymorpha)

Dynavax Technologies

Approval

Recombinant hepatitis B vaccine

Pending Update

Yeast (Hansenula polymorpha)

Hualan Vaccine-Xinxiang

Approval

Recombinant hepatitis B vaccine

Pending Update

Yeast (Hansenula polymorpha)

Aimi Vaccine

Approval

Recombinant hepatitis B vaccine

Bio-Hep-B, reHevbrio, epimmune

CHO cell

VBI vaccine

Approval

Recombinant HBV surface antigen subunit vaccine

Heberbiovac HB

Yeast

Research organization ICGEB

Approval

Recombinant hepatitis B vaccine

Pending Update

CHO cell

Wuhan Biologics, Sinopharm

Approval

Recombinant Hepatitis B Vaccine

Pending Update

CHO cell

Lanzhou Biotech, Sinopharm

Approval

Recombinant hepatitis B vaccine

Recombinant Hepatitis B Vaccine

Yeast (Saccharomyces cerevisiae)

Shenzhen Kangtai Biotechnology

Approval

Hepatitis B vaccine recombinant

Shanvac B

Pending Update

Sanofi

Approval

Recombinant hepatitis B vaccine

GerVax

CHO cell system

North China Pharmaceutical Jintan Biotechnology

Approval

Hepatitis B virus infection

BEVAC

Pending Update

Biological E

Approval

Hepatitis B vaccine recombinant

Pending Update

Pending Update

Combitech

Approval

Hepatitis B vaccine

Pending Update

Pending Update

BioNet

Approval

VBI-2601

VBI 2601, BRII-179

Pending Update

VBI Vaccines, Brii Biosciences

Phase II

Recombinant hepatitis B vaccine

Recombinant Hepatitis B Vaccine (Yeast)

Yeast (Hansenula polymorpha)

Beijing Minhai

Phase I
Reference:

Cid R, Bolívar J. Platforms for Production of Protein-Based Vaccines: From Classical to Next-Generation Strategies. Biomolecules. 2021 Jul 21;11(8):1072. doi: 10.3390/biom11081072.

Mohsen MO, Bachmann MF. Virus-like particle vaccinology, from bench to bedside. Cell Mol Immunol. 2022 Sep;19(9):993-1011. doi: 10.1038/s41423-022-00897-8.

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