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Hepatitis B recombinant vaccine
This recombinant vaccine stimulates the immune system to produce antibodies against hepatitis B surface antigen, providing protection against hepatitis B virus infection.
This recombinant vaccine 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 virus infection in unvaccinated or non-immune individuals.
At a glance
| Generic name | Hepatitis B recombinant vaccine |
|---|---|
| Also known as | Engerix-B vaccine |
| Sponsor | Pontificia Universidad Catolica de Chile |
| 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 (HBsAg) produced through genetic engineering, typically in yeast or mammalian cell systems. When administered, it triggers both humoral and cellular immune responses, leading to the production of anti-HBs antibodies and memory B cells that protect against subsequent exposure to the hepatitis B virus.
Approved indications
- Prevention of hepatitis B virus infection in unvaccinated or non-immune individuals
Common side effects
- Injection site pain or swelling
- Fever
- Fatigue
- Headache
Key clinical trials
- 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)
- Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts (PHASE3)
- Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults (PHASE2)
- Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults (PHASE1, PHASE2)
- TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B (PHASE1)
- Safety and Immunogenicity of a Naked DNA-based Vaccine Therapy in Patients With Chronic Hepatitis B (PHASE1)
- A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection (PHASE1, 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 |
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