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Engerix B
Engerix B is a recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg).
Engerix B is a recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg). 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 |
|---|---|
| Also known as | There are no other names. |
| Sponsor | Crucell Holland BV |
| Drug class | Recombinant 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 produced in yeast cells, which is adsorbed onto aluminum hydroxide as an adjuvant. When administered, it triggers both humoral and cellular immune responses, leading to the production of protective antibodies (anti-HBs) and memory B cells that provide long-term immunity against hepatitis B virus infection.
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
- Fever
- Fatigue
- Headache
- 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 CI brief — competitive landscape report
- Engerix B updates RSS · CI watch RSS
- Crucell Holland BV portfolio CI