{"id":"hbv-mpl-208129","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions (pain, erythema, swelling)"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Myalgia"}]},"_chembl":{"chemblId":"CHEMBL5917849","moleculeType":null,"molecularWeight":"445.93"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine is designed to enhance T-cell and B-cell immunity against HBV by presenting viral antigens alongside MPL, a toll-like receptor 4 agonist that acts as an immunological adjuvant. This approach aims to boost the patient's own immune system to control or clear chronic HBV infection. The combination of antigen and adjuvant is intended to overcome the immune tolerance that typically develops in chronic HBV carriers.","oneSentence":"HBV-MPL 208129 is a therapeutic vaccine that combines hepatitis B virus (HBV) antigens with MPL (monophosphoryl lipid A) adjuvant to stimulate immune responses against chronic HBV infection.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:14:51.964Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic hepatitis B infection"}]},"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":2,"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 208129","genericName":"HBV-MPL 208129","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"HBV-MPL 208129 is a therapeutic vaccine that combines hepatitis B virus (HBV) antigens with MPL (monophosphoryl lipid A) adjuvant to stimulate immune responses against chronic HBV infection. Used for Chronic hepatitis B infection.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}