Drug intelligence / Profile preview

recombinant hepatitis B vaccine (hansenula polymorpha, CpG and aluminum adjuvant)

Development stage
Unknown
Lead developer
Grandway SaviXin Life Sciences
Modality
Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

This is a recombinant protein subunit vaccine designed for the prevention of Hepatitis B virus (HBV) infection. The vaccine utilizes the Hepatitis B surface antigen (HBsAg) expressed in the methylotrophic yeast *Hansenula polymorpha*. A key feature of this formulation is its dual-adjuvant system, combining a synthetic CpG oligodeoxynucleotide (specifically CpG-QCX1), which acts as a Toll-like receptor 9 (TLR9) agonist to stimulate cellular immunity, with a traditional aluminum-based adjuvant to enhance the humoral response. Developed by Grandway SaviXin Life Sciences (Nanjing) Co., Ltd., the vaccine is currently in Phase II clinical trials to evaluate its safety and immunogenicity, particularly focusing on optimized adjuvant ratios and immunization schedules in adults.

Other names
Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, CpG and Aluminum Adjuvant)
02

Targets

TLR9 (Toll-like receptor 9)NLRP3 (Nod-like receptor family pyrin domain-containing protein 3)HBsAg-specific BCR (HBsAg-specific B-cell receptor)T-cell receptor recognizing Hepatitis B surface antigen-derived peptide–MHC class II complexesHepatitis B surface antigen-specific T-cell receptor

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