{"id":"mtbvac","safety":{"commonSideEffects":[{"rate":null,"effect":"Local injection site reactions (erythema, induration, pain)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"MTBVAC is a genetically modified live vaccine derived from M. tuberculosis with deletions in two genes (RD1 and panCD) that reduce virulence while preserving immunogenicity. It is designed to induce both cellular and humoral immune responses to protect against TB infection and disease progression. The vaccine aims to provide superior protection compared to the standard BCG vaccine, particularly in preventing pulmonary TB in adolescents and adults.","oneSentence":"MTBVAC is a live attenuated tuberculosis vaccine that stimulates immune responses against Mycobacterium tuberculosis to prevent active TB disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:22:20.158Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Tuberculosis prevention in adolescents and adults (Phase 3)"}]},"trialDetails":[{"nctId":"NCT05947890","phase":"PHASE2","title":"Evaluating the Safety and Immunogenicity of MTBVAC","status":"RECRUITING","sponsor":"HIV Vaccine Trials Network","startDate":"2024-01-30","conditions":"HIV I Infection, Tuberculosis","enrollment":276},{"nctId":"NCT06272812","phase":"PHASE2","title":"A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.","status":"RECRUITING","sponsor":"International AIDS Vaccine Initiative","startDate":"2025-02-19","conditions":"Tuberculosis (TB)","enrollment":5500},{"nctId":"NCT06997367","phase":"PHASE2","title":"Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)","status":"RECRUITING","sponsor":"Bharat Biotech International Limited","startDate":"2025-03-01","conditions":"Tuberculosis (TB)","enrollment":164},{"nctId":"NCT06438978","phase":"PHASE1","title":"Tuberculosis Vaccine in Healthy Indian Adults","status":"COMPLETED","sponsor":"Bharat Biotech International Limited","startDate":"2024-01-19","conditions":"Tuberculosis","enrollment":30},{"nctId":"NCT03536117","phase":"PHASE2","title":"Dose-Defining Safety and Immunogenicity Study of MTBVAC in South African Neonates","status":"COMPLETED","sponsor":"Biofabri, S.L","startDate":"2019-02-12","conditions":"Tuberculosis","enrollment":99},{"nctId":"NCT04975178","phase":"PHASE3","title":"Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa","status":"RECRUITING","sponsor":"Biofabri, S.L","startDate":"2022-10-17","conditions":"Tuberculosis","enrollment":7120},{"nctId":"NCT02933281","phase":"PHASE1, PHASE2","title":"MTBVAC Study in Adults With and Without Latent Tuberculosis Infection in South Africa","status":"COMPLETED","sponsor":"International AIDS Vaccine Initiative","startDate":"2018-05-14","conditions":"Tuberculosis","enrollment":144},{"nctId":"NCT03767946","phase":"","title":"Epidemiological Study In Tuberculosis-Endemic Urban Area in Senegal","status":"COMPLETED","sponsor":"Biomedical Research Center EPLS","startDate":"2018-07-27","conditions":"Tuberculosis","enrollment":500},{"nctId":"NCT02729571","phase":"PHASE1, PHASE2","title":"Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults","status":"COMPLETED","sponsor":"Biofabri, S.L","startDate":"2015-09","conditions":"Tuberculosis","enrollment":54},{"nctId":"NCT02013245","phase":"PHASE1","title":"Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.","status":"COMPLETED","sponsor":"Biofabri, S.L","startDate":"2013-01","conditions":"Tuberculosis, Healthy","enrollment":36}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":50,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["BBV169"],"phase":"phase_3","status":"active","brandName":"MTBVAC","genericName":"MTBVAC","companyName":"International AIDS Vaccine Initiative","companyId":"international-aids-vaccine-initiative","modality":"Biologic","firstApprovalDate":"","aiSummary":"MTBVAC is a live attenuated tuberculosis vaccine that stimulates immune responses against Mycobacterium tuberculosis to prevent active TB disease. Used for Tuberculosis prevention in adolescents and adults (Phase 3).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}