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HB-AS02V
HB-AS02V is a therapeutic vaccine designed to stimulate immune responses against hepatitis B surface antigen.
HB-AS02V is a therapeutic vaccine designed to stimulate immune responses against hepatitis B surface antigen. Used for Chronic hepatitis B infection, Hepatitis B prevention.
At a glance
| Generic name | HB-AS02V |
|---|---|
| Sponsor | Henogen |
| Drug class | Therapeutic vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
HB-AS02V combines hepatitis B surface antigen with an adjuvant system to enhance immunogenicity and promote both cellular and humoral immune responses. The vaccine is intended to generate protective antibodies and T-cell responses against hepatitis B virus, potentially for use in chronic hepatitis B patients or as a preventive vaccine.
Approved indications
- Chronic hepatitis B infection
- Hepatitis B prevention
Common side effects
- Injection site reactions
- Fever
- Fatigue
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
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |