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Commercial Hepatitis B vaccine
A hepatitis B vaccine that stimulates the immune system to produce antibodies and cellular immunity against hepatitis B virus surface antigen, providing protection against HBV infection.
A hepatitis B vaccine that stimulates the immune system to produce antibodies and cellular immunity against hepatitis B virus surface antigen, providing protection against HBV infection. Used for Prevention of hepatitis B virus infection in unvaccinated or non-immune populations, Post-exposure prophylaxis in hepatitis B-exposed individuals.
At a glance
| Generic name | Commercial Hepatitis B vaccine |
|---|---|
| Also known as | Engerix B |
| Sponsor | Vaxine Pty Ltd |
| Drug class | Vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains hepatitis B surface antigen (HBsAg), typically produced via recombinant DNA technology, which triggers both humoral (antibody) and cell-mediated immune responses. This immune priming enables the body to recognize and neutralize hepatitis B virus upon exposure, preventing infection and chronic disease development.
Approved indications
- Prevention of hepatitis B virus infection in unvaccinated or non-immune populations
- Post-exposure prophylaxis in hepatitis B-exposed individuals
Common side effects
- Injection site pain, redness, or swelling
- Fatigue
- Headache
- Myalgia
- Low-grade fever
Key clinical trials
- A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection (PHASE1, PHASE2)
- UHN Inpatient Hepatitis C & B Screening (PHASE4)
- Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose (PHASE3)
- Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age (PHASE3)
- HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg (PHASE3)
- An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B
- Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB (PHASE3)
- Study of the Influence of Vaccination in HIV Viral Load and Immunologic Responses Against HIV (PHASE4)
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:
- Commercial Hepatitis B vaccine CI brief — competitive landscape report
- Commercial Hepatitis B vaccine updates RSS · CI watch RSS
- Vaxine Pty Ltd portfolio CI