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Drug

hepatitis B surface antigen vaccine

Established medicine
ResearchActive indication expansion
Also known as Antigen of Hepatitis B virus surface protein, Comvax, Engerix-B, HBSAG+17 more

Antigen of Hepatitis B virus surface protein, Comvax, Engerix-B, HBSAG, HEPATITIS B, HEPATITIS B SURFACE ANTIGEN, HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN, Hep B, unspecified formulation, Hepatitis B Vaccine, Hepatitis B surface antigens, Hepatitis B virus hbsag surface protein antigen, Hepatitis-B surface antigen, Heplisav-B, PEDIARIX, PreHevbrio, Recombivax, Twinrix, Vaxelis, hepatitis B vaccine, unspecified formulation, hepatitis B virus vaccine, Hepatitis B Surface Antigen (rDNA).

RxNorm797752
4
Research papers
4
Active clinical trials
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Occult hepatitis B virus infection

Industry2026-09-14Nature Reviews Gastroenterology & Hepatology

GSK snags Japanese approval for first hepatitis B functional cure, Hibsago

Regulatory2026-08-25Regulatory news · Pharmaceutical Technology

TwinStrand wins patent case; GSK’s hepatitis B drug approved in Japan

Regulatory2026-08-24Regulatory news · Endpoints News

[Comment] Launch of the Africa CDC toolkit for hepatitis B: bringing care closer to people in Africa

Industry2026-07-27The Lancet Gastroenterology & Hepatology

A Randomized, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Combination With Hepatitis B Vaccine or Pegylated Interferon α-2b (Peg-IFN) in Participants With HBeAg-Negative Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogue (NAs)

Clinical trial2026-05-20Results expected Q3 2027 · ClinicalTrials.gov

Prophylactic Vaccines as Therapy: Prevention of Recurrence of Extensive Genital Warts

Clinical trial2026-01-23Results posted · ClinicalTrials.gov

Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers Among Women of Childbearing Age, and Young Adults in Zimbabwe in the Context of Mental Health: a Multimodal, Multifaceted Approach.

Clinical trial2026-01-21Results expected Q3 2031 · ClinicalTrials.gov

HBV Vaccination of Healthy Volunteers to Evaluate the Composition of Germinal Centers

Clinical trial2025-09-29Terminated · ClinicalTrials.gov

An efficient vaccine clinical trial: ACTG A5379 hepatitis B vaccine trial in persons with HIV.

Research2025-03-26Vaccine

HepB-CpG vs HepB-Alum Vaccine in People With HIV and Prior Vaccine Nonresponse: The BEe-HIVe Randomized Clinical Trial.

Research2025-01-01JAMA

Immunogenicity and Safety of Hepatitis B Virus (HBV) Vaccine With a Toll-Like Receptor 9 Agonist Adjuvant in HBV Vaccine-Naïve People With Human Immunodeficiency Virus.

Research2023-08-01Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Comparative immunogenicity under field conditions of two recombinant hepatitis B vaccines in 8-10-year-old children.

Research2000-02-01Vaccine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
hepatitis B surface antigen vaccine
Aliases & brands
Antigen of Hepatitis B virus surface proteinComvaxEngerix-BHBSAGHEPATITIS BHEPATITIS B SURFACE ANTIGENHEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENHep B, unspecified formulationHepatitis B VaccineHepatitis B surface antigensHepatitis B virus hbsag surface protein antigenHepatitis-B surface antigenHeplisav-BPEDIARIXPreHevbrioRecombivaxTwinrixVaxelishepatitis B vaccine, unspecified formulationhepatitis B virus vaccineHepatitis B Surface Antigen (rDNA)
RxNorm CUI
797752

Clinical trials

97 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
97
registered trials across all phases
LATEST COMPLETION 2025
4
Active studies
4
Recruiting
67
Late-stage (III+)
75
Completed
18
Discontinued
PHASE DISTRIBUTIONn = 97
Early Phase 11Phase 116Phase 1 / 21Phase 212Phase 323Phase 431Phase N / A13

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers Among Women of Childbearing Age, and Young Adults in Zimbabwe in the Context of Mental Health: a Multimodal, Multifaceted Approach.

Not yet recruitingPH IVKey trialEunice Duben=1,8002031

HBV Vaccination of Healthy Volunteers to Evaluate the Composition of Germinal Centers

TerminatedPH IVRockefeller Universityn=92025

Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection: an Open-label Randomized Clinical Trial

Unknown statusPH IVNational Taiwan University Hospitaln=5752023

Demonstration Project on Health Care Worker Protection Against Hepatitis B in Kalulushi District

CompletedPH IVCentre for Infectious Disease Research in Zambian=6412020

Efficacy of HBV Therapeutic Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy: a Pilot Study

CompletedPH IVChang Gung Memorial Hospitaln=1162018

Recent completions

Trials that read out recently, adding to the completed evidence base.

Prophylactic Vaccines as Therapy: Prevention of Recurrence of Extensive Genital Warts

CompletedPH IIIUniversity of Pretorian=522025

B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

CompletedPH IIINational Institute of Allergy and Infectious Diseases (NIAID)n=6382024

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

CompletedPH IIISanofi Pasteur, a Sanofi Companyn=9502023

A Phase III, Partially Modified Double-blind, Randomized, Parallel-group, Active-controlled, Multi-center Study to Compare the Immunogenicity and Describe the Safety of MenACYW Conjugate Vaccine and MENVEO® When Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in the United States

CompletedPH IIIKey trialSanofi Pasteur, a Sanofi Companyn=2,6272023

A Randomized Study to Describe the Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

CompletedPH IIIKey trialSanofi Pasteur, a Sanofi Companyn=2,7972023

Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity

CompletedN/ABoston Children's Hospitaln=9112022

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20002025
Major research themes5
Hepatitis B3Hepatitis B Vaccines2HIV Infections2Adjuvants, Immunologic1Hepatitis B virus1
Journals, researchers & institutions
Top journals
  • Vaccine2
  • Clinical infectious diseases : an official publication of the Infectious Diseases Society of America1
  • JAMA1
Leading researchers
  • Kang M3
  • Marks KM3
  • Sherman KE3
  • Cox AL2
  • Katsidzira L2
  • Perazzo H2
  • Umbleja T2
  • Alston-Smith B1
Leading institutions
free-text, unnormalised
  • Center for Biostatistics in AIDS Research in the Department of Biostatistics2
  • National Institute of Allergy and Infectious Diseases2
  • University of Zimbabwe2
  • Botswana Harvard AIDS Institute Partnership1
  • Centre de recherche du CHUQ - Pavillon CHUL1
  • Chiang Mai University1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials