{"id":"gamtbvac","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"GamTBvac is a recombinant viral vector-based vaccine designed to boost cellular and humoral immune responses in tuberculosis patients. It uses a viral platform to deliver TB antigens, aiming to enhance the body's ability to control active or latent TB infection. The vaccine is intended for use as an adjunctive immunotherapy in combination with standard anti-TB chemotherapy.","oneSentence":"GamTBvac is a therapeutic tuberculosis vaccine that stimulates immune responses against Mycobacterium tuberculosis antigens to enhance host immunity and control infection.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:13:44.117Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Tuberculosis (active disease, as adjunct to standard chemotherapy)"},{"name":"Latent tuberculosis infection"}]},"trialDetails":[{"nctId":"NCT04975737","phase":"PHASE3","title":"Study of the Safety and Efficacy of the Subunit Recombinant Tuberculosis Vaccine GamTBvac","status":"UNKNOWN","sponsor":"Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation","startDate":"2022-01-20","conditions":"Tuberculosis","enrollment":7180},{"nctId":"NCT03878004","phase":"PHASE2","title":"Phase II Clinical Trial of Safety and Immunogenicity of Recombinant Subunit Tuberculosis Vaccine GamTBvac","status":"COMPLETED","sponsor":"Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation","startDate":"2018-12-01","conditions":"Healthy","enrollment":180},{"nctId":"NCT03255278","phase":"PHASE1","title":"Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine \"GamTBvac\" Against the Tuberculosis.","status":"COMPLETED","sponsor":"Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation","startDate":"2017-01-15","conditions":"Tuberculosis","enrollment":60}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"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":"GamTBvac","genericName":"GamTBvac","companyName":"Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation","companyId":"gamaleya-research-institute-of-epidemiology-and-microbiology-health-ministry-of","modality":"Biologic","firstApprovalDate":"","aiSummary":"GamTBvac is a therapeutic tuberculosis vaccine that stimulates immune responses against Mycobacterium tuberculosis antigens to enhance host immunity and control infection. Used for Tuberculosis (active disease, as adjunct to standard chemotherapy), Latent tuberculosis infection.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}