{"id":"lc16m8","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions (erythema, induration, pain)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"LC16m8 is a modified vaccinia virus Ankara (MVA)-derived vaccine candidate that replicates in mammalian cells to trigger both humoral and cellular immune responses against orthopoxviruses. The vaccine strain was derived from the LC16 vaccine lineage, which has a history of clinical use in Japan. It is intended to provide protection against smallpox and monkeypox through induction of neutralizing antibodies and T-cell mediated immunity.","oneSentence":"LC16m8 is a live attenuated vaccinia virus vaccine designed to provide immunization against smallpox and monkeypox through viral replication and immune stimulation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:49:18.009Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Smallpox prevention"},{"name":"Monkeypox prevention"}]},"trialDetails":[{"nctId":"NCT07093489","phase":"","title":"Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)","status":"NOT_YET_RECRUITING","sponsor":"International Vaccine Institute","startDate":"2025-09-30","conditions":"Mpox (Monkeypox), Mpox","enrollment":11990},{"nctId":"NCT06223919","phase":"PHASE3","title":"Efficacy/Effectiveness, Safety, and Immunogenicity of LC16m8 Mpox Vaccine in Colombia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Universidad Nacional de Colombia","startDate":"2023-12-16","conditions":"Monkeypox","enrollment":8686},{"nctId":"NCT00103584","phase":"PHASE1, PHASE2","title":"Safety and Immunogenicity Study of LC16m8, a Modified Smallpox Vaccine, in Healthy, Previously Unvaccinated Volunteers","status":"UNKNOWN","sponsor":"VaxGen","startDate":"2004-10","conditions":"Smallpox","enrollment":150}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":73,"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":"LC16m8","genericName":"LC16m8","companyName":"International Vaccine Institute","companyId":"international-vaccine-institute","modality":"Biologic","firstApprovalDate":"","aiSummary":"LC16m8 is a live attenuated vaccinia virus vaccine designed to provide immunization against smallpox and monkeypox through viral replication and immune stimulation. Used for Smallpox prevention, Monkeypox prevention.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}