Hepatitis B vaccine

ApprovedVaccine

Sanofi

Hepatitis B vaccine is one of 223 biologic programs targeting Poliomyelitis. It is currently in Approved.

Indications

Total Trials

Active Trials

222

Competitors

Pipeline

Status by Indication[3][1]

Indication

PoliomyelitisActive, not recruiting

HepatitisActive, not recruiting

Chronic HepatitisActive, not recruiting

MemoryActive, not recruiting

Hepatitis BActive, not recruiting

Celiac DiseaseActive, not recruiting

Kidney FailureActive, not recruiting

PapillomaActive, not recruiting

PoliomyelitisPhase 2

Active, not recruiting

HepatitisPhase 3

Active, not recruiting

Chronic HepatitisApproved

Active, not recruiting

MemoryPreclinical

Active, not recruiting

Hepatitis BPhase 3

Active, not recruiting

Celiac DiseasePreclinical

Active, not recruiting

Kidney FailurePhase 1

Active, not recruiting

PapillomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

624 competitors in Chronic Hepatitis

#DrugCompanyPhaseTrials

Hepatitis B vaccine

Sanofi

Approved

1 2

PEG-Intron

Merck & Co.

Preclinical

43 3

Sovaldi

Gilead

Preclinical

34 4

Virazole

CConrado Roberto Hoffmann Filho

Preclinical

199 5

Incivek

Vertex Pharmaceuticals

Preclinical

10 6

Intron a

Sanofi

Preclinical

7 7

Roferon-a

Roche

Preclinical

3 8

Medrol

Pfizer

Preclinical

1 9

Dasabuvir

AbbVie

Preclinical

7 10

SOF/VEL

Gilead

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Vaccination

NCT05272735

Q2 2027

Phase 2Active, not recruiting

Hepatitis B

NCT07069569

Q1 2029

Phase 3Not yet recruiting

Hepatitis B

NCT06888479

Clinical

Trials by Indication[1]

Hepatitis B21 trials

Immunogenicity of Influenza, Pneumococcal and Hepatitis B Vaccines in IBD Patients Treated With Vedolizumab

Completed·—··NCT03056924·173 enrolled

Strategies for the Prevention of Hepatitis B Among HIV Infected Patients in Uganda

Completed·FFred Hutchinson Cancer Center·Phase 4·NCT02316444·132 enrolled

Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)

Terminated· Emergent BioSolutions logo

Emergent BioSolutions·Phase 3·NCT01311674·141 enrolled

Show 18 more trials

The Hepatitis B Vaccine Booster Response Among the Youth Who Had Completed Neonatal Hepatitis B Vaccines

Completed·NNational Taiwan University Hospital·N/A·NCT00792610·127 enrolled

Persistence of the Immune Response to Hepatitis B in 4-6 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

Completed· GSK logo

GSK·Phase 4·NCT00335881·300 enrolled

VaxTeen Hepatitis B Vaccine Booster Study

Completed·CCenters for Disease Control and Prevention·Phase 4·NCT00144313·60 enrolled

Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

Completed· GSK logo

GSK·Phase 4·NCT00356564·350 enrolled

Response to Booster Doses of Hepatitis B Vaccine in Children and Adolescents

Completed·CCenters for Disease Control and Prevention··NCT00141999·400 enrolled

Optimal Timing of Hepatitis B Vaccination After Transplants

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 3·NCT06888479·1,500 enrolled

A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults

Completed·PPeking University·Phase 4·NCT02203357·353 enrolled

New Methods to Measure the Immune Response to Hepatitis B Vaccine

Completed·UUniversity of Oxford·Phase 4·NCT01821547·21 enrolled

Dose of Hepatitis B Vaccines in Non/Low-response Populations

Completed·WWu Jiang·N/A·NCT01564134·537 enrolled

Comparison of Monodose and Multidose Presentations of GSK Biologicals' Hepatitis B Vaccine in Terms of Immune Response

Completed· GSK logo

GSK·Phase 4·NCT00197158·280 enrolled

A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs

Active, not recruiting·AAusper Biopharma Co., Ltd.·Phase 2·NCT07069569·127 enrolled

Immunity to Hepatitis B Vaccine

Completed·UUniversity of British Columbia·Phase 4·NCT03083158·16 enrolled

The Effect of Alendronate on the Immune Response to Hepatitis B Vaccine in Healthy Adults

Completed·MMassachusetts General Hospital·Phase 1·NCT02057263·28 enrolled

A Trial Investigating the Influence of BCG and Hepatitis B Immunisation at Birth on Neonatal Immune Responses: The Early Life Vaccines and Immunity Study

Completed·MMurdoch Childrens Research Institute·N/A·NCT02444611·185 enrolled

Immunologic Response of Hepatitis B Vaccine

Unknown status·—·Phase 4·NCT03219203·80 enrolled

Adolescents' Response to Hepatitis B Vaccine Booster Dose

Unknown status·—·Phase 4·NCT01341275·400 enrolled

A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00414050·1,718 enrolled

Efficacy of Hepatitis B Vaccine Boosters Among Neonatally Vaccinated Children in Chongqing

Unknown status·—··NCT03867643·80 enrolled

Immunogenicity8 trials

Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico

Completed· Sanofi logo

Sanofi·Phase 3·NCT03630705·525 enrolled

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US

Completed· Sanofi logo

Sanofi·Phase 3·NCT03537508·2,627 enrolled

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

Completed· Sanofi logo

Sanofi·Phase 3·NCT03691610·950 enrolled

Show 5 more trials

Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule

Completed· Sanofi logo

Sanofi·Phase 3·NCT00315055·310 enrolled

A Controlled Study to Evaluate the Safety and Immunogenicity of StreptAnova™ in Healthy Adults

Unknown status·—·Phase 1·NCT02564237·39 enrolled

Safety and Immunogenicity of Co-Administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 in Gabonese Adults

Completed·—·Phase 1·NCT02126462·32 enrolled

Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity

Completed·—·N/A·NCT03246230·911 enrolled

A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000745·72 enrolled

Immune System4 trials

Improving the Immune System With Human IL-7 Vaccine in Older Subjects Who Have Had Chemotherapy

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01339000·1 enrolled

Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00257127·101 enrolled

Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001119·288 enrolled

Show 1 more trial

A Study to Test If Giving Remune (an HIV Vaccine) Can Improve the Immune Systems of HIV-Positive Patients Who Are Also Participating in ACTG 328

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000943·50 enrolled

Immune Response3 trials

Safety of and Immune Response to Vaccination With 2 Experimental HIV Vaccines in Healthy Adults

Completed·HHIV Vaccine Trials Network·Phase 1·NCT02109354·202 enrolled

Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine

Completed· GSK logo

GSK·Phase 4·NCT00329576·632 enrolled

Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab

Completed· Takeda logo

Takeda·Phase 1·NCT01981616·127 enrolled

Children3 trials

Phase Ib Trial of MSP3 LSP in Children in Tanzania

Unknown status·AAfrican Malaria Network Trust·Phase 1·NCT00469651·45 enrolled

Study of Co-administered Na-APR-1 (M74) and Na-GST-1 in Gabonese Children

Completed·—·Phase 1·NCT02839161·60 enrolled

A Phase Ib Trial of MSP 3 LSP in 1-2 Year Old Children in Burkina Faso

Unknown status·AAfrican Malaria Network Trust·Phase 1·NCT00452088·45 enrolled

14 more indications

Papilloma2 trials

Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts

Completed·UUniversity of Pretoria·Phase 3·NCT02750202·52 enrolled

Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

Completed·XXiamen University·Phase 2·NCT01356823·1,600 enrolled

Vaccine2 trials

A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers

Completed· Sanofi logo

Sanofi·Phase 2·NCT01049035·580 enrolled

HBV Vaccine in Anti-core Positive Donors After LT

Unknown status·HHospital Clinic of Barcelona·Phase 2·NCT04442841·114 enrolled

Vaccination2 trials

HBV Vaccination in HIV-infected Adults

Unknown status·—·Phase 4·NCT03212911·96 enrolled

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

Recruiting·RRockefeller University·Phase 4·NCT05272735·12 enrolled

Poliomyelitis1 trial

Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis

Completed· Sanofi logo

Sanofi·Phase 2·NCT02040636·277 enrolled

Hepatitis1 trial

Clinical Trial of Recombinant Hepatitis E Vaccine

Completed·XXiamen University·Phase 3·NCT01014845·112,604 enrolled

Respiratory Syncytial Virus1 trial

Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers

Terminated· Sanofi logo

Sanofi·Phase 3·NCT06397768·2,226 enrolled

Pediatric1 trial

Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Completed· Sanofi logo

Sanofi·Phase 3·NCT03673462·2,797 enrolled

Chronic Hepatitis1 trial

Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients

Completed·TTongji Hospital·Phase 4·NCT02360592·94 enrolled

Memory1 trial

Antibody Response and Immune Memory 15-18 Years After HBV Vaccination

Unknown status·NNational Taiwan University Hospital·N/A·NCT00172328

Celiac Disease1 trial

Response to Hepatitis B Vaccine in Celiac Disease Patients

Terminated·SShaare Zedek Medical Center·N/A·NCT00739128·210 enrolled

HIV Seropositive1 trial

A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000633·55 enrolled

Kidney Failure1 trial

Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients

Completed·DDynavax Technologies Corporation·Phase 1·NCT00426712·42 enrolled

Gene Expression1 trial

Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers

Completed·RRockefeller University·N/A·NCT02055365·10 enrolled

Immunization1 trial

Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00013871·300 enrolled

Sources

References

[1]
ClinicalTrials.gov — 56 trial records for Hepatitis B vaccine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Hepatitis B vaccine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Hepatitis B vaccine. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Vaccine[2]
Highest Phase: Approved[1]
Company: Sanofi

Hepatitis B vaccine

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q1 2029

Trials by Indication[1]

Hepatitis B21 trials

Immunogenicity8 trials

Immune System4 trials

Immune Response3 trials

Children3 trials

Papilloma2 trials

Vaccine2 trials

Vaccination2 trials

Poliomyelitis1 trial

Hepatitis1 trial

Respiratory Syncytial Virus1 trial

Pediatric1 trial

Chronic Hepatitis1 trial

Memory1 trial

Celiac Disease1 trial

HIV Seropositive1 trial

Kidney Failure1 trial

Gene Expression1 trial

Immunization1 trial

References

Drug Info

Quick Facts

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