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Hepa-B
Hepa-B is a hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen, providing protection against hepatitis B virus infection.
Hepa-B is a hepatitis B vaccine that 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 infants, children, and adults.
At a glance
| Generic name | Hepa-B |
|---|---|
| Also known as | Hepatitis B virus (HBV) vaccine |
| Sponsor | International Centre for Diarrhoeal Disease Research, Bangladesh |
| Drug class | Vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains hepatitis B surface antigen (HBsAg), typically produced through recombinant DNA technology, which triggers both humoral and cellular immune responses. This leads to the production of protective antibodies (anti-HBs) and memory B cells that provide long-term immunity against hepatitis B virus infection.
Approved indications
- Prevention of hepatitis B virus infection in infants, children, and adults
Common side effects
- Injection site pain or swelling
- Fever
- Fatigue
- Headache
Key clinical trials
- Effects of Aging on Primary and Secondary Vaccine Responses (PHASE1)
- Effectiveness Trial to Evaluate Protection of Pregnant Women by Hepatitis E Vaccine in Bangladesh. (PHASE4)
- Non Inferiority Trial of Locally Manufactured 'Hepa-B' Vaccine in Bangladesh. (PHASE2, PHASE3)
- Influence of Indoor Air Filtration Strategies on Occupant Health Indicators (NA)
- Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers (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:
- Hepa-B CI brief — competitive landscape report
- Hepa-B updates RSS · CI watch RSS
- International Centre for Diarrhoeal Disease Research, Bangladesh portfolio CI