{"id":"bacille-calmette-gu-rin-bcg","safety":{"commonSideEffects":[{"rate":"40-60","effect":"Dysuria"},{"rate":"40-60","effect":"Urinary frequency"},{"rate":"20-40","effect":"Hematuria"},{"rate":"10-20","effect":"Fever"},{"rate":"10-20","effect":"Malaise"},{"rate":"<1","effect":"BCG sepsis (rare)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BCG works by activating dendritic cells, macrophages, and T cells through pattern recognition receptors, triggering a robust Th1-mediated immune response. When instilled directly into the bladder, it promotes local and systemic anti-tumor immunity, leading to destruction of urothelial cancer cells and prevention of recurrence. The mechanism also involves non-specific immune activation and direct cytotoxic effects on cancer cells.","oneSentence":"BCG is a live attenuated mycobacterial vaccine that stimulates innate and adaptive immune responses to enhance anti-tumor immunity and treat bladder cancer.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:28:16.075Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-muscle invasive bladder cancer (NMIBC), high-grade or recurrent"},{"name":"Bladder cancer prophylaxis after transurethral resection"}]},"trialDetails":[{"nctId":"NCT05327647","phase":"PHASE2","title":"A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer","status":"RECRUITING","sponsor":"CHU de Quebec-Universite Laval","startDate":"2022-06-23","conditions":"Non-Muscle Invasive Bladder Cancer","enrollment":160},{"nctId":"NCT01906853","phase":"PHASE3","title":"Melbourne Infant Study - Bacille Calmette Guérin (BCG) for Allergy & Infection Reduction","status":"COMPLETED","sponsor":"Murdoch Childrens Research Institute","startDate":"2013-07","conditions":"Allergy, Eczema, Respiratory Tract Infections","enrollment":1272},{"nctId":"NCT03888924","phase":"PHASE2","title":"Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS)","status":"RECRUITING","sponsor":"S. Andrea Hospital","startDate":"2019-06-17","conditions":"Multiple Sclerosis","enrollment":100},{"nctId":"NCT04327206","phase":"PHASE3","title":"BCG Vaccination to Protect Healthcare Workers Against COVID-19","status":"COMPLETED","sponsor":"Murdoch Childrens Research Institute","startDate":"2020-03-30","conditions":"Coronavirus Disease 2019 (COVID-19), Respiratory Illness, Corona Virus Infection","enrollment":6828},{"nctId":"NCT03892642","phase":"PHASE1, PHASE2","title":"Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer","status":"COMPLETED","sponsor":"University of Oklahoma","startDate":"2019-05-01","conditions":"Bladder Cancer","enrollment":18},{"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":"NCT05330884","phase":"PHASE3","title":"BCG Revaccination in Children and Adolescents","status":"SUSPENDED","sponsor":"Tuberculosis Research Centre, India","startDate":"2024-07-15","conditions":"Tuberculosis Infection, Tuberculosis","enrollment":9200},{"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":"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 Healthcare Workers in COVID-19 Pandemic","status":"COMPLETED","sponsor":"TASK Applied Science","startDate":"2020-05-04","conditions":"COVID-19, Sars-CoV2","enrollment":1000},{"nctId":"NCT02792192","phase":"PHASE1, PHASE2","title":"Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Participants","status":"TERMINATED","sponsor":"Hoffmann-La Roche","startDate":"2016-06-13","conditions":"Bladder Cancer","enrollment":24},{"nctId":"NCT04922047","phase":"PHASE1, PHASE2","title":"Safety and Efficacy Study of Tislelizumab in Combination With BCG in HR-NMIBC Patients (TACBIN-01)","status":"UNKNOWN","sponsor":"RenJi Hospital","startDate":"2021-06","conditions":"Urinary Bladder Neoplasms, Urologic Neoplasms, Urogenital Neoplasms","enrollment":6},{"nctId":"NCT02953327","phase":"PHASE4","title":"Testing if BCG (Bacille Calmette-Guérin) Vaccination Can Induce Innate Immune Training in Adult People Above 50 Years of Age in Guinea-Bissau","status":"COMPLETED","sponsor":"Bandim Health Project","startDate":"2017-02-01","conditions":"Innate Immunity, Bacille Calmette-Guérin","enrollment":40},{"nctId":"NCT04417335","phase":"PHASE4","title":"Reducing COVID-19 Related Hospital Admission in Elderly by BCG Vaccination","status":"UNKNOWN","sponsor":"Radboud University Medical Center","startDate":"2020-04-16","conditions":"COVID-19","enrollment":2014},{"nctId":"NCT00462488","phase":"PHASE2","title":"Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ","status":"COMPLETED","sponsor":"Sesen Bio, Inc.","startDate":"2007-03","conditions":"Urinary Bladder Cancer, Bladder Cancer, Bladder Neoplasms","enrollment":46},{"nctId":"NCT02444611","phase":"NA","title":"A Trial Investigating the Influence of BCG and Hepatitis B Immunisation at Birth on Neonatal Immune Responses: The Early Life Vaccines and Immunity Study","status":"COMPLETED","sponsor":"Murdoch Childrens Research Institute","startDate":"2015-03","conditions":"Innate Immune Response","enrollment":185},{"nctId":"NCT01694108","phase":"PHASE4","title":"Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children.","status":"COMPLETED","sponsor":"Lone Graff Stensballe","startDate":"2012-09","conditions":"Prospective, Single-blind, Clinical","enrollment":4262},{"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":"NCT02085590","phase":"PHASE2, PHASE3","title":"Effects of BCG on Immune Response","status":"COMPLETED","sponsor":"Radboud University Medical Center","startDate":"2014-03","conditions":"Sepsis","enrollment":20},{"nctId":"NCT02088892","phase":"NA","title":"A Clinical Challenge Study of BCG in Healthy Volunteers","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2014-03","conditions":"Tuberculosis","enrollment":52},{"nctId":"NCT01879163","phase":"PHASE1","title":"Phase I Trial Evaluating Safety and Immunogenicity of MVA85A-IMX313 Compared to MVA85A in BCG Vaccinated Adults","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2013-07","conditions":"Tuberculosis (TB)","enrollment":30},{"nctId":"NCT01420705","phase":"","title":"Bacille Calmette-Guérin (BCG) Vaccine and Atopy","status":"COMPLETED","sponsor":"Bandim Health Project","startDate":"2011-10","conditions":"Asthma, Eczema, Food Hypersensitivity","enrollment":487}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2173,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["BCG-Vaccin SSI [Statens Serum Institut], Danish strain 1331"],"phase":"marketed","status":"active","brandName":"Bacille Calmette-Guérin (BCG)","genericName":"Bacille Calmette-Guérin (BCG)","companyName":"TASK Applied Science","companyId":"task-applied-science","modality":"Biologic","firstApprovalDate":"","aiSummary":"BCG is a live attenuated mycobacterial vaccine that stimulates innate and adaptive immune responses to enhance anti-tumor immunity and treat bladder cancer. Used for Non-muscle invasive bladder cancer (NMIBC), high-grade or recurrent, Bladder cancer prophylaxis after transurethral resection.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}