Drug intelligence / Profile preview

hepatitis b vaccine recombinant AS04-adjuvanted

Development stage
Phase 3
Lead developer
GSK
Modality
Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
Administration
Intramuscular
01

Overview

**Hepatitis b vaccine recombinant AS04-adjuvanted** is a vaccine formulated to prevent infection by hepatitis B virus (HBV). It contains recombinant hepatitis B surface antigen (HBsAg) and is adjuvanted with AS04, a combination of aluminum hydroxide and monophosphoryl lipid A (MPL), which enhances immune response. The AS04 adjuvant stimulates Toll-like receptor 4 (TLR4) on antigen-presenting cells, leading to increased cytokine production and stronger, more balanced Th1/Th2 immune responses, especially producing more robust antibody and T cell responses compared to aluminum-only adjuvants. This formulation is particularly used for populations with poor responses to standard vaccines, such as patients with chronic kidney disease or those on dialysis. The primary indication is prevention of HBV infection, and the vaccine is approved for adults, especially those at risk for poor vaccine response[2][4][6][8].

Brand names
Fendrix
Other names
hepatitis B vaccine AS04-adjuvantedrecombinant hepatitis B vaccine AS04AS04 HepB vaccineAS-04 HepB vaccineAS 04 HepB vaccine
02

Targets

HBsAg (Hepatitis B surface antigen)TLR4 (Toll-like receptor 4)

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