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HBV-MPL 208129
HBV-MPL 208129 is a therapeutic vaccine that combines hepatitis B virus (HBV) antigens with MPL (monophosphoryl lipid A) adjuvant to stimulate immune responses against chronic HBV infection.
HBV-MPL 208129 is a therapeutic vaccine that combines hepatitis B virus (HBV) antigens with MPL (monophosphoryl lipid A) adjuvant to stimulate immune responses against chronic HBV infection. Used for Chronic hepatitis B infection.
At a glance
| Generic name | HBV-MPL 208129 |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Therapeutic vaccine |
| Target | HBV antigens; TLR4 (via MPL adjuvant) |
| Modality | Biologic |
| Therapeutic area | Immunology / Virology |
| Phase | Phase 3 |
Mechanism of action
The vaccine is designed to enhance T-cell and B-cell immunity against HBV by presenting viral antigens alongside MPL, a toll-like receptor 4 agonist that acts as an immunological adjuvant. This approach aims to boost the patient's own immune system to control or clear chronic HBV infection. The combination of antigen and adjuvant is intended to overcome the immune tolerance that typically develops in chronic HBV carriers.
Approved indications
- Chronic hepatitis B infection
Common side effects
- Injection site reactions (pain, erythema, swelling)
- Fatigue
- Headache
- Myalgia
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 208129 CI brief — competitive landscape report
- HBV-MPL 208129 updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI