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HBV-MPL vaccine (208129)
HBV-MPL vaccine stimulates immune response against hepatitis B virus by combining hepatitis B surface antigen with MPL (monophosphoryl lipid A), a toll-like receptor 4 agonist adjuvant.
HBV-MPL vaccine stimulates immune response against hepatitis B virus by combining hepatitis B surface antigen with MPL (monophosphoryl lipid A), a toll-like receptor 4 agonist adjuvant. Used for Hepatitis B prevention in adults.
At a glance
| Generic name | HBV-MPL vaccine (208129) |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Recombinant hepatitis B vaccine with adjuvant |
| Target | Hepatitis B surface antigen (HBsAg); TLR4 (via MPL adjuvant) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine presents HBsAg to the immune system while MPL acts as an immunological adjuvant that enhances and directs the adaptive immune response toward a Th1-biased cellular and humoral immunity. This combination approach aims to generate stronger and more durable antibody responses and cell-mediated immunity against hepatitis B infection compared to non-adjuvanted vaccines.
Approved indications
- Hepatitis B prevention in adults
Common side effects
- Injection site pain or erythema
- Fatigue
- Myalgia
- Headache
Key clinical trials
- Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y (PHASE3)
- Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control (PHASE3)
- Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype (PHASE3)
- Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age (PHASE3)
- Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients (PHASE1)
- Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults (PHASE2)
- Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B (PHASE3)
- Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- HBV-MPL vaccine (208129) CI brief — competitive landscape report
- HBV-MPL vaccine (208129) updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI