{"id":"hbv-mpl-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain or erythema"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine presents HBsAg to the immune system while MPL acts as a toll-like receptor 4 agonist to boost innate immune signaling, promoting stronger and more durable antibody and cellular immune responses against hepatitis B. This combination approach aims to improve immunogenicity compared to non-adjuvanted HBV vaccines, particularly in populations with weaker baseline immune responses such as older adults or immunocompromised individuals.","oneSentence":"HBV-MPL vaccine stimulates immune response against hepatitis B virus by combining hepatitis B surface antigen with MPL (monophosphoryl lipid A), an adjuvant that enhances T-cell and B-cell activation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:14:52.709Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of hepatitis B infection in adults"}]},"trialDetails":[{"nctId":"NCT02942277","phase":"PHASE1","title":"Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2016-10-21","conditions":"Malaria","enrollment":301},{"nctId":"NCT04515368","phase":"NA","title":"A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity","status":"COMPLETED","sponsor":"Imperial College London","startDate":"2016-06-10","conditions":"Positron-Emission Tomography, Immunization Reaction","enrollment":54},{"nctId":"NCT00698061","phase":"PHASE3","title":"Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1999-11","conditions":"Hepatitis B","enrollment":145},{"nctId":"NCT00697866","phase":"PHASE3","title":"Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2000-08","conditions":"Hepatitis B","enrollment":951},{"nctId":"NCT00697749","phase":"PHASE3","title":"Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1999-04","conditions":"Hepatitis B","enrollment":230},{"nctId":"NCT00697554","phase":"PHASE3","title":"Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2000-01","conditions":"Hepatitis B","enrollment":93},{"nctId":"NCT00699231","phase":"PHASE1","title":"Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1992-02","conditions":"Hepatitis B","enrollment":30},{"nctId":"NCT00698555","phase":"PHASE2","title":"Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1997-03","conditions":"Hepatitis B","enrollment":163},{"nctId":"NCT00698906","phase":"PHASE2","title":"Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 y","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1997-06","conditions":"Hepatitis B","enrollment":160},{"nctId":"NCT00697775","phase":"PHASE2","title":"Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1998-03","conditions":"Hepatitis B","enrollment":200},{"nctId":"NCT00697853","phase":"PHASE2","title":"Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1998-11","conditions":"Hepatitis 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Vaccine and Engerix™-B in Adult Non-Responders","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1997-05","conditions":"Hepatitis B","enrollment":116},{"nctId":"NCT00697229","phase":"PHASE2","title":"Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1992-09","conditions":"Hepatitis B","enrollment":99},{"nctId":"NCT00696891","phase":"PHASE3","title":"Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1997-06","conditions":"Hepatitis B","enrollment":380},{"nctId":"NCT00697242","phase":"PHASE3","title":"Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1994-01","conditions":"Hepatitis B","enrollment":362},{"nctId":"NCT00697125","phase":"PHASE2","title":"Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1993-06","conditions":"Hepatitis B","enrollment":60},{"nctId":"NCT00696917","phase":"PHASE3","title":"Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1999-04","conditions":"Hepatitis B","enrollment":1303},{"nctId":"NCT00697216","phase":"PHASE3","title":"Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1997-03","conditions":"Hepatitis B","enrollment":340}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":306030,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"HBV-MPL vaccine","genericName":"HBV-MPL vaccine","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"HBV-MPL vaccine stimulates immune response against hepatitis B virus by combining hepatitis B surface antigen with MPL (monophosphoryl lipid A), an adjuvant that enhances T-cell and B-cell activation. Used for Prevention of hepatitis B infection in adults.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}