Last reviewed · How we verify
Hepatitis B adjuvanted vaccine
This vaccine stimulates the immune system to produce antibodies and cellular immunity against hepatitis B virus by presenting hepatitis B surface antigen with an adjuvant that enhances the immune response.
This vaccine stimulates the immune system to produce antibodies and cellular immunity against hepatitis B virus by presenting hepatitis B surface antigen with an adjuvant that enhances the immune response. Used for Prevention of hepatitis B infection in adults, Prevention of hepatitis B infection in adolescents and children.
At a glance
| Generic name | Hepatitis B adjuvanted vaccine |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains recombinant hepatitis B surface antigen (HBsAg) combined with an adjuvant system (AS04, containing aluminum hydroxide and MPL) that amplifies both humoral and cell-mediated immune responses. The adjuvant enhances antigen presentation to B and T cells, resulting in stronger and more durable antibody production and memory immune responses compared to non-adjuvanted formulations. This leads to protective immunity against hepatitis B infection.
Approved indications
- Prevention of hepatitis B infection in adults
- Prevention of hepatitis B infection in adolescents and children
Common side effects
- Injection site pain
- Injection site redness
- Injection site swelling
- Fatigue
- Myalgia
- Headache
- Fever
Key clinical trials
- Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection (PHASE1, PHASE2)
- Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults (PHASE1)
- Vaccine Responses in Patients With B Cell Malignancies (PHASE4)
- A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years (PHASE1)
- A Study on the Safety, Efficacy and Immune Response Following Sequential Treatment With an Anti-sense Oligonucleotide Against Chronic Hepatitis B (CHB) and Chronic Hepatitis B Targeted Immunotherapy (CHB-TI) in CHB Patients Receiving Nucleos(t)Ide Analogue (NA) Therapy (PHASE2)
- Understanding Poor Vaccine Responses to Hepatitis B Vaccination (PHASE4)
- HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB) (PHASE2)
- Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults (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:
- Hepatitis B adjuvanted vaccine CI brief — competitive landscape report
- Hepatitis B adjuvanted vaccine updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI