{"id":"bcg-bulgaria","safety":{"commonSideEffects":[{"rate":null,"effect":"Local reaction at injection site (erythema, induration)"},{"rate":null,"effect":"Regional lymphadenitis"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"BCG-itis (disseminated infection, rare)"}]},"_chembl":{"chemblId":"CHEMBL2108905","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BCG is a live vaccine derived from an attenuated strain of Mycobacterium bovis. It works by activating both innate immunity (through pattern recognition receptors) and adaptive immunity (Th1 and Th17 cell responses), priming the immune system against tuberculosis and potentially providing non-specific immunological benefits. The Bulgarian strain is a specific regional variant of the BCG vaccine.","oneSentence":"BCG-Bulgaria is a live attenuated Mycobacterium bovis bacillus Calmette-Guérin vaccine that stimulates innate and adaptive immune responses to provide immunological protection.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:20:30.282Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Tuberculosis prevention"},{"name":"Bladder cancer (intravesical BCG therapy)"}]},"trialDetails":[{"nctId":"NCT05397678","phase":"PHASE4","title":"Trial to Compare BCG-Bulgaria and BCG-Denmark","status":"UNKNOWN","sponsor":"Bandim Health Project","startDate":"2022-10-21","conditions":"Death; Neonatal, Death, Infant, Morbidity;Newborn","enrollment":15000},{"nctId":"NCT06178666","phase":"NA","title":"A Controlled Human Infection Model (CHIM) With Intradermal BCG in Malawi","status":"UNKNOWN","sponsor":"Liverpool School of Tropical Medicine","startDate":"2024-03-01","conditions":"Tuberculosis","enrollment":30},{"nctId":"NCT02709278","phase":"PHASE1","title":"Aerosol BCG Challenge Trial in Healthy UK Adults","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2016-03-07","conditions":"Tuberculosis","enrollment":46},{"nctId":"NCT03296423","phase":"PHASE4","title":"Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly","status":"COMPLETED","sponsor":"Hellenic Institute for the Study of Sepsis","startDate":"2017-09-21","conditions":"Infection, Hospitalization, Mortality","enrollment":200}],"_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":["BCG-Sofia"],"phase":"marketed","status":"active","brandName":"BCG-Bulgaria","genericName":"BCG-Bulgaria","companyName":"Bandim Health Project","companyId":"bandim-health-project","modality":"Biologic","firstApprovalDate":"","aiSummary":"BCG-Bulgaria is a live attenuated Mycobacterium bovis bacillus Calmette-Guérin vaccine that stimulates innate and adaptive immune responses to provide immunological protection. Used for Tuberculosis prevention, Bladder cancer (intravesical BCG therapy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}