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Engerix B Hepatitis B Vaccine
Engerix B stimulates the immune system to produce antibodies against hepatitis B surface antigen, conferring protection against hepatitis B virus infection.
Engerix B stimulates the immune system to produce antibodies against hepatitis B surface antigen, conferring protection against hepatitis B virus infection. Used for Prevention of hepatitis B infection in infants, children, and adults.
At a glance
| Generic name | Engerix B Hepatitis B Vaccine |
|---|---|
| Sponsor | Tel-Aviv Sourasky Medical Center |
| Drug class | Hepatitis B vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
This vaccine contains recombinant hepatitis B surface antigen (HBsAg) produced in yeast cells. Upon administration, it triggers both humoral and cellular immune responses, leading to the production of anti-HBs antibodies 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
Common side effects
- Injection site pain or soreness
- 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 Hepatitis B Vaccine CI brief — competitive landscape report
- Engerix B Hepatitis B Vaccine updates RSS · CI watch RSS
- Tel-Aviv Sourasky Medical Center portfolio CI