Hepatitis B Virus Hbsag Surface Protein Antigen
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Also known as Adsorbed hepatitis b vaccineAmbirixFendrixHbsagHbvaxproHepatitis b antigenHepatitis b surface antigenHepatitis b surface antigen (rdna)Hepatitis b surface antigensHepatitis b vaccineHepatitis b vaccine (recombinant)Hepatitis b vaccine recombinantHepatitis b virus vaccineHepatitis-b surface antigenHeplisav bPrehevbriProcomvaxTwinrix adultTwinrix paediatric
Summary
Hepatitis B Virus Hbsag Surface Protein Antigen (CHEMBL4297973) is an approved vaccine component; indicated across 22 conditions including hepatitis b virus infection and chronic hepatitis b virus infection.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Vaccine component
- Indications: 22 conditions
- Clinical trials: 75
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4297973 |
| Name | Hepatitis B Virus Hbsag Surface Protein Antigen |
| Type | Vaccine component |
| Max phase | 4 |
Also known as: Adsorbed hepatitis b vaccine, Ambirix, Fendrix, Hbsag, Hbvaxpro, Hepatitis b antigen, Hepatitis b surface antigen, Hepatitis b surface antigen (rdna), Hepatitis b surface antigens, Hepatitis b vaccine, Hepatitis b vaccine (recombinant), Hepatitis b vaccine recombinant
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
22 indications (9 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| hepatitis B virus infection | 4 | MONDO:0005344 | EFO:0004197 |
| chronic hepatitis B virus infection | 4 | MONDO:0005366 | EFO:0004239 |
| pertussis | 4 | MONDO:0005077 | EFO:0000650 |
| diphtheria | 4 | MONDO:0005504 | EFO:0005549 |
| tetanus | 4 | MONDO:0005526 | EFO:0005593 |
| hepatitis A virus infection | 4 | MONDO:0005790 | EFO:0007305 |
| poliomyelitis | 4 | MONDO:0017373 | EFO:0007450 |
| haemophilus meningitis | 4 | MONDO:0000889 | EFO:1000955 |
| meningococcal infection | 3 | MONDO:0005373 | EFO:0004249 |
| anogenital human papillomavirus infection | 3 | MONDO:0005647 | EFO:0007147 |
| hepatitis E virus infection | 3 | MONDO:0005788 | EFO:0007303 |
| streptococcal infection | 3 | MONDO:0021680 | EFO:1001476 |
| HIV infectious disease | 2 | MONDO:0005109 | EFO:0000764 |
| cirrhosis of liver | 2 | MONDO:0005155 | EFO:0001422 |
| malaria | 1 | MONDO:0005136 | EFO:0001068 |
| inflammatory bowel disease | 1 | MONDO:0005265 | EFO:0003767 |
| hookworm infectious disease | 1 | MONDO:0005799 | EFO:0007314 |
| schistosomiasis | 1 | MONDO:0015254 | EFO:1001475 |
| exocrine pancreatic carcinoma | 1 | MONDO:0005192 | EFO:0002618 |
| common wart | 1 | MONDO:0001209 | EFO:0009662 |
2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 75.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE3 | 18 |
| PHASE4 | 17 |
| PHASE1 | 14 |
| Not specified | 14 |
| PHASE2 | 10 |
| PHASE2/PHASE3 | 1 |
| PHASE1/PHASE2 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00144313 | PHASE4 | COMPLETED | VaxTeen Hepatitis B Vaccine Booster Study |
| NCT00197158 | PHASE4 | COMPLETED | Comparison of Monodose and Multidose Presentations of GSK Biologicals’ Hepatitis B Vaccine in Terms of Immune Response |
| NCT00230061 | PHASE4 | COMPLETED | Hepatitis B Vaccination in HIV-infected Persons |
| NCT00329576 | PHASE4 | COMPLETED | Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine |
| NCT00335881 | PHASE4 | COMPLETED | Persistence of the Immune Response to Hepatitis B in 4-6 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib |
| NCT00356564 | PHASE4 | COMPLETED | Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib |
| NCT00603252 | PHASE4 | COMPLETED | Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults |
| NCT00684671 | PHASE4 | COMPLETED | Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination |
| NCT01341275 | PHASE4 | UNKNOWN | Adolescents’ Response to Hepatitis B Vaccine Booster Dose |
| NCT01821547 | PHASE4 | COMPLETED | New Methods to Measure the Immune Response to Hepatitis B Vaccine |
| NCT02203357 | PHASE4 | COMPLETED | A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults |
| NCT02316444 | PHASE4 | COMPLETED | Strategies for the Prevention of Hepatitis B Among HIV Infected Patients in Uganda |
| NCT02360592 | PHASE4 | COMPLETED | Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients |
| NCT03083158 | PHASE4 | COMPLETED | Immunity to Hepatitis B Vaccine |
| NCT03212911 | PHASE4 | UNKNOWN | HBV Vaccination in HIV-infected Adults |
| NCT03219203 | PHASE4 | UNKNOWN | Immunologic Response of Hepatitis B Vaccine |
| NCT05272735 | PHASE4 | TERMINATED | HBV Vaccination of Healthy Volunteers to Evaluate the Composition of Germinal Centers |
| NCT06888479 | PHASE3 | NOT_YET_RECRUITING | Optimal Timing of Hepatitis B Vaccination After Transplants |
| NCT00291941 | PHASE3 | COMPLETED | A Study to Compare the Immune Response and Safety Elicited by Henogen’s Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B. |
| NCT00291954 | PHASE3 | COMPLETED | Compare the Immune Response & Safety Elicited by Henogen’s Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD’s Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination |
| NCT00291980 | PHASE3 | COMPLETED | A Study to Compare the Immune Response and Safety Elicited by Henogen’s Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD’s Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody. |
| NCT00315055 | PHASE3 | COMPLETED | Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule |
| NCT00414050 | PHASE3 | COMPLETED | A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057) |
| NCT00445185 | PHASE3 | COMPLETED | Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen’s HBV Vaccine, or Fendrix™ |
| NCT00841477 | PHASE3 | COMPLETED | An Hepatitis B Vaccine Model for HIV Vaccine Trials in Drug Users |
| NCT01014845 | PHASE3 | COMPLETED | Clinical Trial of Recombinant Hepatitis E Vaccine |
| NCT01195246 | PHASE3 | COMPLETED | Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis |
| NCT01311674 | PHASE3 | TERMINATED | Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG) |
| NCT02012998 | PHASE3 | COMPLETED | Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA |
| NCT02434848 | PHASE2/PHASE3 | COMPLETED | A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses |
| NCT02750202 | PHASE3 | COMPLETED | Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts |
| NCT03537508 | PHASE3 | COMPLETED | Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US |
| NCT03630705 | PHASE3 | COMPLETED | 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 |
| NCT03673462 | PHASE3 | COMPLETED | Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers |
| NCT03691610 | PHASE3 | COMPLETED | Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers |
| NCT06397768 | PHASE3 | TERMINATED | Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers |
| NCT07069569 | PHASE2 | RECRUITING | A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs |
| NCT00100633 | PHASE1/PHASE2 | COMPLETED | Safety of and Immune Response to a Hepatitis B Virus Vaccine Given With a Booster (CpG7909 ODN) in HIV Infected and HIV Uninfected People |
| NCT00272493 | PHASE2 | COMPLETED | Safety and Effectiveness of an Adjuvant in Improving Immune Response to Hepatitis B Virus Vaccine in HIV Infected Individuals |
| NCT00697125 | PHASE2 | COMPLETED | Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).