Drug intelligence / Profile preview

hepatitis b vaccine recombinant AS04-adjuvanted

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

TLR4 (Toll-like receptor 4)

Beyond the preview

Go deeper on hepatitis b vaccine recombinant AS04-adjuvanted.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Full profile access

Follow clinical development from study design and recruitment through results.

  • Trial phase
  • Status
  • Readouts

Indications & development

Full profile access

Explore development by indication, patient population, and geography.

  • Indications
  • Development status
  • Countries

Licensing & deals

Full profile access

Trace asset ownership, licensing agreements, and commercial partnerships.

  • Partners
  • Deal terms
  • Milestones

Patents & exclusivity

Full profile access

Explore the patent landscape and regulatory exclusivity around an asset.

  • Patents
  • Expiration dates
  • Exclusivity

Competitive landscape

Full profile access

Compare development programs by target, modality, and indication.

  • Competing assets
  • Targets
  • Development stage

Research & analysis

Full profile access

Connect source evidence and development news to your research questions.

  • Publications
  • News
  • Analysis

Bring the full picture into focus.

See how Gosset can support your research on hepatitis b vaccine recombinant AS04-adjuvanted.

Explore the full profile

Gosset Free

Get started with Gosset.

Enter your work email and we’ll be in touch with next steps.

Work email preferred.

Book a call