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Modified Process Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine is a Vaccine Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Prevention of hepatitis B infection in infants, children, and adults. Also known as: HBVaxPro.
This vaccine stimulates the immune system to produce antibodies against hepatitis B surface antigen, providing protection against hepatitis B virus infection.
This vaccine 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 infection in infants, children, and adults.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Modified Process Hepatitis B Vaccine |
|---|---|
| Also known as | HBVaxPro |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Modified Process Hepatitis B Vaccine is an inactivated vaccine containing hepatitis B surface antigen (HBsAg) produced through recombinant DNA technology. It works by presenting the viral antigen to the immune system, triggering both humoral (antibody) and cellular immune responses that confer protective immunity against hepatitis B infection. The vaccine is administered in a series of doses to establish and maintain adequate antibody titers.
Approved indications
- Prevention of hepatitis B infection in infants, children, and adults
Common side effects
- Injection site pain or swelling
- Fever
- Fatigue
- Headache
- Myalgia
Key clinical trials
- MENJAGA: Continuous Quality Improvement for Antenatal HIV, Syphilis and Hepatitis B Testing in Indonesia (NA)
- Chronic Hepatitis B Patients With Concurrent MAFLD: Cohort Study and Exercise Intervention. (NA)
- Hepatitis B Challenge Dose in Adults (V232-059-10) (PHASE3)
- A Basic-clinical Translational Research in Hepatitis B Virus (HBV)-Specific Antigen Peptides and HepG2 Cell Lysate Co-activated Dendritic Cells Combined With Transarterial Chemoembolization (TACE) in HBV-related HCC Treatment (BTRHBVAPHCLCDCCTCHBVHCCT) (PHASE1, PHASE2)
- 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)
- Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060) (PHASE3)
- Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(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:
- Modified Process Hepatitis B Vaccine CI brief — competitive landscape report
- Modified Process Hepatitis B Vaccine updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Modified Process Hepatitis B Vaccine
What is Modified Process Hepatitis B Vaccine?
How does Modified Process Hepatitis B Vaccine work?
What is Modified Process Hepatitis B Vaccine used for?
Who makes Modified Process Hepatitis B Vaccine?
Is Modified Process Hepatitis B Vaccine also known as anything else?
What drug class is Modified Process Hepatitis B Vaccine in?
What development phase is Modified Process Hepatitis B Vaccine in?
What are the side effects of Modified Process Hepatitis B Vaccine?
What does Modified Process Hepatitis B Vaccine target?
Related
- Drug class: All Vaccine drugs
- Target: All drugs targeting Hepatitis B surface antigen (HBsAg)
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Prevention of hepatitis B infection in infants, children, and adults
- Also known as: HBVaxPro
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing