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Engerix-B vaccine
Engerix-B stimulates the immune system to produce antibodies against hepatitis B surface antigen, providing protection against hepatitis B virus infection.
Engerix-B stimulates the immune system to produce antibodies against hepatitis B surface antigen, providing protection against hepatitis B virus infection. Used for Prevention of hepatitis B infection in infants, children, and adults, Post-exposure prophylaxis for hepatitis B.
At a glance
| Generic name | Engerix-B vaccine |
|---|---|
| Also known as | HBV vaccine, HBV |
| Sponsor | GlaxoSmithKline |
| Drug class | Recombinant vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Engerix-B is a recombinant hepatitis B vaccine containing hepatitis B surface antigen (HBsAg) produced in yeast cells. When administered, it triggers both humoral and cellular immune responses, leading to the production of protective antibodies (anti-HBs) and memory B cells. This immune response provides long-term protection against hepatitis B virus infection and disease.
Approved indications
- Prevention of hepatitis B infection in infants, children, and adults
- Post-exposure prophylaxis for hepatitis B
Common side effects
- Injection site soreness or swelling
- Fatigue
- Headache
- Fever
- Myalgia
Key clinical trials
- The COMBAT HBV Feasibility Trial (PHASE4)
- A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years (PHASE1)
- Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults (PHASE1, PHASE2)
- A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection (PHASE1, PHASE2)
- Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants (PHASE2)
- B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B (PHASE3)
- Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III) (PHASE3)
- The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort (NA)
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:
- Engerix-B vaccine CI brief — competitive landscape report
- Engerix-B vaccine updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI