HBV Vaccine

Modality

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.

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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Modality

Hepatitis B Virus (HBV) Vaccine

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

HBV VLP Vaccines Pipelines

Reference:

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