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HB-AS02V vaccine
HB-AS02V is a therapeutic vaccine designed to stimulate immune responses against hepatitis B surface antigen to treat chronic hepatitis B infection.
HB-AS02V is a therapeutic vaccine designed to stimulate immune responses against hepatitis B surface antigen to treat chronic hepatitis B infection. Used for Chronic hepatitis B infection.
At a glance
| Generic name | HB-AS02V vaccine |
|---|---|
| Sponsor | Henogen |
| Drug class | Therapeutic vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology / Virology |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains hepatitis B surface antigen (HBsAg) combined with an adjuvant system (AS02V) to enhance immunogenicity. It aims to boost T-cell and B-cell responses in chronically infected patients, potentially leading to viral clearance or functional cure of hepatitis B.
Approved indications
- Chronic hepatitis B infection
Common side effects
- Injection site reactions
- Fever
- Fatigue
- Myalgia
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 Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody. (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:
- HB-AS02V vaccine CI brief — competitive landscape report
- HB-AS02V vaccine updates RSS · CI watch RSS
- Henogen portfolio CI