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Henogen HB vaccine
Henogen HB vaccine stimulates the immune system to produce antibodies and cellular immunity against hepatitis B virus surface antigen.
Henogen HB vaccine stimulates the immune system to produce antibodies and cellular immunity against hepatitis B virus surface antigen. Used for Prevention of hepatitis B infection in unvaccinated or non-responsive populations.
At a glance
| Generic name | Henogen HB vaccine |
|---|---|
| Sponsor | Henogen |
| Drug class | Recombinant hepatitis B vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains hepatitis B surface antigen (HBsAg) produced via recombinant DNA technology, which triggers both humoral and cell-mediated immune responses. This leads to the production of anti-HBs antibodies and memory B cells that provide long-term protection against hepatitis B infection. The vaccine may also include adjuvants to enhance immunogenicity.
Approved indications
- Prevention of hepatitis B infection in unvaccinated or non-responsive populations
Common side effects
- Injection site pain or swelling
- Fever
- Fatigue
- Headache
Key clinical trials
- Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™ (PHASE3)
- Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination (PHASE3)
- A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B. (PHASE3)
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:
- Henogen HB vaccine CI brief — competitive landscape report
- Henogen HB vaccine updates RSS · CI watch RSS
- Henogen portfolio CI