{"id":"bcg-vaccine-ssi","safety":{"commonSideEffects":[{"rate":"50-90","effect":"Local reaction at injection site (erythema, induration)"},{"rate":"1-10","effect":"Regional lymphadenitis"},{"rate":"1-5","effect":"Fever"},{"rate":"<0.1","effect":"Disseminated BCG infection (rare, in immunocompromised)"}]},"_chembl":{"chemblId":"CHEMBL2108905","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BCG (Bacillus Calmette-Guérin) is a live attenuated mycobacterium that triggers both cellular and humoral immune responses. It activates dendritic cells, macrophages, and T cells to generate protective immunity against Mycobacterium tuberculosis. The vaccine also has non-specific immunostimulatory properties that enhance general immune competence and have been explored for off-label therapeutic applications.","oneSentence":"BCG vaccine stimulates the immune system by activating innate and adaptive immunity to provide protection against tuberculosis and has immunomodulatory effects that may benefit other conditions.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:20:34.512Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Tuberculosis prevention"},{"name":"Bladder cancer (intravesical immunotherapy)"}]},"trialDetails":[{"nctId":"NCT04152161","phase":"PHASE2","title":"Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection","status":"TERMINATED","sponsor":"Gates Medical Research Institute","startDate":"2019-10-16","conditions":"Tuberculosis","enrollment":1836},{"nctId":"NCT04542330","phase":"PHASE3","title":"Using BCG to Protect Senior Citizens During the COVID-19 Pandemic","status":"COMPLETED","sponsor":"Bandim Health Project","startDate":"2020-09-15","conditions":"Covid19, Non-specific Effects of Vaccines, Heterologous Immunity","enrollment":1700},{"nctId":"NCT05766345","phase":"PHASE4","title":"BCG-induced Epigenetic Modifications in the NEXT Generation","status":"UNKNOWN","sponsor":"Radboud University Medical Center","startDate":"2023-10-02","conditions":"Trained Immunity, BCG Vaccine, Epigenetics","enrollment":36},{"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":"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":"NCT05820594","phase":"NA","title":"Using BCG Vaccine to Understand Tuberculosis Infection","status":"UNKNOWN","sponsor":"Liverpool School of Tropical Medicine","startDate":"2023-06-30","conditions":"Tuberculosis","enrollment":30},{"nctId":"NCT03947138","phase":"PHASE3","title":"A Study of GC3107(BCG Vaccine) in Healthy Infants","status":"COMPLETED","sponsor":"Green Cross Corporation","startDate":"2019-08-06","conditions":"BCG Vaccination Reaction, Tuberculosis","enrollment":750},{"nctId":"NCT04537663","phase":"PHASE4","title":"Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults","status":"COMPLETED","sponsor":"UMC Utrecht","startDate":"2020-09-07","conditions":"Respiratory Tract Infections, Covid19","enrollment":6112},{"nctId":"NCT04379336","phase":"PHASE3","title":"BCG Vaccination for 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Safety and Immunogenicity of BCG and AERAS-404 in HIV-Negative, TB-Negative, BCG-Naive Adults","status":"COMPLETED","sponsor":"Aeras","startDate":"2011-01","conditions":"Tuberculosis","enrollment":70},{"nctId":"NCT02380508","phase":"NA","title":"Heterologous Effects of BCG in Healthy UK Adults","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2015-02","conditions":"Tuberculosis","enrollment":36},{"nctId":"NCT02771782","phase":"PHASE4","title":"Influence of BCG on TDaP-IPV Vaccination","status":"UNKNOWN","sponsor":"Radboud University Medical Center","startDate":"2015-01","conditions":"Whooping Cough","enrollment":75},{"nctId":"NCT02259608","phase":"NA","title":"γ-irradiated BCG to Train Innate Immunity","status":"COMPLETED","sponsor":"Radboud University Medical Center","startDate":"2013-11","conditions":"Innate Immune Response","enrollment":15},{"nctId":"NCT02175420","phase":"NA","title":"Role of BCG as Booster Vaccination","status":"COMPLETED","sponsor":"Radboud 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Center","companyId":"radboud-university-medical-center","modality":"Biologic","firstApprovalDate":"","aiSummary":"BCG vaccine stimulates the immune system by activating innate and adaptive immunity to provide protection against tuberculosis and has immunomodulatory effects that may benefit other conditions. Used for Tuberculosis prevention, Bladder cancer (intravesical immunotherapy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}