Last reviewed · How we verify
RECOMBIVAX HB™
RECOMBIVAX HB is a recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg), providing protection against hepatitis B virus infection.
RECOMBIVAX HB is a recombinant hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen (HBsAg), providing protection against hepatitis B virus infection. Used for Prevention of hepatitis B infection in infants, children, and adults, Post-exposure prophylaxis for hepatitis B.
At a glance
| Generic name | RECOMBIVAX HB™ |
|---|---|
| Also known as | V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced. |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Recombinant vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains recombinant hepatitis B surface antigen produced in yeast cells via recombinant DNA technology. When administered, it triggers both humoral and cellular immune responses, leading to the production of protective antibodies (anti-HBs) and memory B cells. This immunological memory provides long-term protection against hepatitis B infection.
Approved indications
- Prevention of hepatitis B infection in infants, children, and adults
- Post-exposure prophylaxis for hepatitis B
Common side effects
- Injection site soreness or swelling
- Fatigue
- Headache
- Fever (≥37.7°C)
- Myalgia
Key clinical trials
- Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029) (PHASE3)
- A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION) (PHASE3)
- A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006) (PHASE3)
- Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005) (PHASE3)
- Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062) (PHASE3)
- 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)
- Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED) (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:
- RECOMBIVAX HB™ CI brief — competitive landscape report
- RECOMBIVAX HB™ updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI