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Drug intelligence / Profile preview
adjuvanted hepatitis B vaccine HB-AS02V
- Development stage
- Phase 3
- Lead developer
- GSK
- Modality
- Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
- Administration
- Intramuscular
01
Overview
The adjuvanted hepatitis B vaccine HB-AS02V is an investigational vaccine designed to induce protective immunity against hepatitis B virus (HBV), particularly in patients with renal insufficiency and other immunocompromised individuals who often have suboptimal responses to conventional recombinant HBV vaccines. It contains recombinant hepatitis B surface antigen (HBsAg) combined with the AS02 adjuvant system, which is an oil-in-water emulsion that includes monophosphoryl lipid A (MPL; a detoxified derivative of *Salmonella minnesota* lipopolysaccharide) and QS21 (an immunostimulant derived from *Quillaja saponaria* tree bark). The AS02 adjuvant system acts synergistically to stimulate both humoral and cellular (CD4+ Th1) immune responses, producing higher and more persistent anti-HBs antibody levels and T cell responses than standard non-adjuvanted or aluminum-based adjuvant HBV vaccines. HB-AS02V has demonstrated lot-to-lot manufacturing consistency, strong immunogenicity, and favorable safety profiles in clinical trials involving healthy adults and patients with renal insufficiency[1].
- Brand names
- Henogen HB vaccine
- Other names
- investigational adjuvanted hepatitis B vaccine HB-AS02
02
Targets
MHC II (Major histocompatibility complex class II receptor)HBc (Hepatitis B virus core protein)HBsAg (Hepatitis B surface antigen)
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