Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
- Development stage
- Unknown
- Lead developer
- GSK
- Modality
- Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
- Administration
- Intramuscular
01
Overview
HBV-MPL vaccine formulation B is an experimental recombinant hepatitis B vaccine candidate developed by GSK. It consists of the hepatitis B surface antigen (HBsAg) produced in yeast cells, adjuvanted with the AS04C system—a combination of 3-O-desacyl-4′-monophosphoryl lipid A (MPL) and aluminum phosphate. This formulation was designed to provide superior immunogenicity compared to standard aluminum-only adjuvanted vaccines (like Engerix-B) by leveraging MPL's ability to stimulate the TLR4 pathway. It was specifically studied in clinical trials (such as NCT00137319) involving healthy adolescents to evaluate safety and the induction of protective anti-HBs antibody levels. The broader HBV-MPL program eventually resulted in the approval of the vaccine under the brand name Fendrix for specific high-risk populations, such as patients with renal insufficiency.
- Brand names
- Fendrix
- Other names
- HBV-MPL vaccineAS04C-adjuvanted hepatitis B vaccineAS-04C-adjuvanted hepatitis B vaccineAS 04C-adjuvanted hepatitis B vaccinehepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
02
Targets
HBsAg (Hepatitis B surface antigen)TLR4 (Toll-like receptor 4)
Beyond the preview
Go deeper on hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Indications & development
Full profile accessExplore development by indication, patient population, and geography.
- Indications
- Development status
- Countries
Licensing & deals
Full profile accessTrace asset ownership, licensing agreements, and commercial partnerships.
- Partners
- Deal terms
- Milestones
Patents & exclusivity
Full profile accessExplore the patent landscape and regulatory exclusivity around an asset.
- Patents
- Expiration dates
- Exclusivity
Competitive landscape
Full profile accessCompare development programs by target, modality, and indication.
- Competing assets
- Targets
- Development stage
Research & analysis
Full profile accessConnect 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 (rDNA) vaccine (adjuvanted, adsorbed).