Last reviewed · How we verify
Experimental recombinant hepatitis B vaccine
This recombinant hepatitis B vaccine stimulates the immune system to produce antibodies and cellular immunity against hepatitis B virus surface antigen, providing protection against hepatitis B infection.
This recombinant hepatitis B vaccine stimulates the immune system to produce antibodies and cellular immunity against hepatitis B virus surface antigen, providing protection against hepatitis B infection. Used for Prevention of hepatitis B infection in unvaccinated or non-immune populations.
At a glance
| Generic name | Experimental recombinant hepatitis B vaccine |
|---|---|
| Sponsor | Jiangsu Province Centers for Disease Control and Prevention |
| Drug class | Vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains recombinant hepatitis B surface antigen (HBsAg) produced through genetic engineering, typically in yeast or mammalian cell systems. Upon administration, it triggers both humoral (antibody-mediated) and cellular immune responses, leading to the production of anti-HBs antibodies and memory B cells that protect against subsequent exposure to hepatitis B virus.
Approved indications
- Prevention of hepatitis B infection in unvaccinated or non-immune populations
Common side effects
- Injection site pain or swelling
- Fever
- Fatigue
- Headache
Key clinical trials
- A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection (PHASE1, PHASE2)
- Evaluation of Safety, Tolerability and Immune Responses of Ebola-S and Marburg Vaccines in Healthy Adults (PHASE1)
- Clinical Trial of Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, 10μg) (PHASE1)
- A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057) (PHASE3)
- Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED) (PHASE3)
- A Study to Test the Safety and Effectiveness of an Investigational Vaccine in Infants (V419-002) (PHASE2)
- Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED) (PHASE3)
- Chiron Corp HCV E1/E2 Vaccine (PHASE1)
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: