{"id":"hbv-mpl-vaccine-208129","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain or erythema"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine presents HBsAg to the immune system while MPL acts as an immunological adjuvant that enhances and directs the adaptive immune response toward a Th1-biased cellular and humoral immunity. This combination approach aims to generate stronger and more durable antibody responses and cell-mediated immunity against hepatitis B infection compared to non-adjuvanted vaccines.","oneSentence":"HBV-MPL vaccine stimulates immune response against hepatitis B virus by combining hepatitis B surface antigen with MPL (monophosphoryl lipid A), a toll-like receptor 4 agonist adjuvant.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:14:56.603Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hepatitis B prevention in adults"}]},"trialDetails":[{"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":"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 B","enrollment":200},{"nctId":"NCT00697840","phase":"PHASE3","title":"Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1995-06","conditions":"Hepatitis B","enrollment":150},{"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":0,"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 (208129)","genericName":"HBV-MPL vaccine (208129)","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), a toll-like receptor 4 agonist adjuvant. Used for Hepatitis B prevention in adults.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}