44 completed, 12 unknown, 9 active not recruiting, 8 withdrawn. 31 Phase 3, 27 Phase 2, 16 Phase 4, 15 Phase 1, 5 Not applicable.
Follow BCG Vaccine: new trials by email Literature Review of BCG Vaccine trials Research Report on BCG Vaccine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against TB in Pre-Adolescents Living With and Without HIV in South Africa VPM1002 Vaccine, BCG Vaccine, Placebo - Tuberculosis, HIV Infections | Phase 1 / Phase 2 | Withdrawn | International Maternal Pediatric Adolescent AIDS Clinical Trials Group | 2026-12-31 | 2026-08-17 | |
| Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia Bacillus Calmette Guerin Vaccine, Saline Injection - Fibromyalgia | Phase 2 | Withdrawn | Massachusetts General Hospital | 2026-01-01 | 2024-11-21 | |
| Safety and Challenge Study of BCG TICE(R) Vaccination to Test Tuberculosis Immunity in Heathy Humans BCG TICE strain, Sodium Chloride, 0.9%, Sterile Water for Injection - Tuberculosis | Phase 1 | Withdrawn | National Institute of Allergy and Infectious Diseases (NIAID) | 2025-11-26 | 2025-12-17 | |
| A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC. Gemcitabine + BCG, BCG (TICE strain) - NMIBC, Non-Muscle Invasive Bladder Urothelial Carcinoma | Phase 1 / Phase 2 | Not yet recruiting | Queen's University | 31 | 2025-08-01 | 2025-07-17 |
| BCG Revaccination With the Third Dose of Diphtheria-tetanus-pertussis Vaccine and Infant Mortality in Africa BCG Vaccine - Infant Morbidity, Infant Mortality | Phase 4 | Enrolling by invitation | Bandim Health Project | 6000 | 2025-05-09 | 2025-06-12 |
| A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011) Intismeran autogene, BCG - Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms | Phase 2 | Recruiting | Merck Sharp & Dohme LLC | 308 | 2025-03-11 | 2026-10-01 |
| BCG Revaccination in Children and Adolescents BCG vaccine, Oral Chemoprophylaxis - Tuberculosis Infection, Tuberculosis | Phase 3 | Suspended | Tuberculosis Research Centre, India | 9200 | 2024-07-15 | 2023-12-18 |
| Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC) Bacillus Calmette-Guerin: Strain Russian BCG-I, Bacillus Calmette-Guerin: Strain TICE - Bladder Cancer, Bladder Cancer Recurrent | Phase 3 | Recruiting | Verity Pharmaceuticals Inc. | 540 | 2024-04-24 | 2026-03-20 |
| Live Vaccines and Innate Immune Training in COPD. BCG vaccine (Danish strain 1331), MMR Vaccine, Placebo - Trained Innate Immunity, COPD | Phase 4 | Completed | Josefin Eklöf | 60 | 2024-02-28 | 2026-03-19 |
| Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer Disitamab vedotin, Bacillus Calmette Guerin Vaccine - Non-muscle Invasive Bladder Cancer, HER-2 Protein Overexpression | Phase 2 | Active not recruiting | Fudan University | 20 | 2023-12-18 | 2026-07-20 |
| Diabetes Diagnosis, Management, Prevention and Education in Guinea-Bissau BCG vaccine (two doses, 4 weeks apart), Saline placebo (Two doses, 4 weeks apart) - Diabetes Mellitus, BCG Vaccination Reaction | Phase 4 | Active not recruiting | Bandim Health Project | 200 | 2023-12-01 | 2026-02-17 |
| Antibiotics and Vaccine Immune Responses Study BCG vaccine, Yellow Fever vaccine, Vancomycin Oral Capsule - Vaccine Response Impaired | Phase 4 | Recruiting | South Australian Health and Medical Research Institute | 348 | 2023-11-23 | 2026-09-17 |
| Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC) N803 plus Bacillus Calmette-Guerin (BCG) - Non Muscle Invasive Bladder Cancer | Active not recruiting | ImmunityBio, Inc. | 6 | 2023-08-17 | 2026-04-29 | |
| Does BCG Vaccination Reduce Biomarkers of Alzheimer's Disease? BCG vaccine - Alzheimer Disease, Late Onset | Early Phase 1 | Enrolling by invitation | Tamir Ben-Hur | 60 | 2023-07-01 | 2025-03-18 |
| Using BCG Vaccine to Understand Tuberculosis Infection Intradermal BCG (bacillus calmette-guerin) vaccine AJV - Tuberculosis | Not applicable | Unknown | Liverpool School of Tropical Medicine | 30 | 2023-06-30 | 2023-07-07 |
| Effect of Intravesical B.C.G and Gemcitabine on Semen Analysis and Testicular Volume in NMIBC Bacillus Calmette Guerin, Gemcitabine HCL (Gemzar) - Urothelial Carcinoma Bladder, Sperm Count, Low | Phase 4 | Completed | Assiut University | 86 | 2023-04-01 | 2026-10-29 |
| Intravesical BCG vs GEMDOCE in NMIBC Gemcitabine, Docetaxel, Bacillus Calmette Guerin - Non-muscle-invasive Bladder Cancer | Phase 3 | Active not recruiting | ECOG-ACRIN Cancer Research Group | 870 | 2023-02-07 | 2026-09-15 |
| Prevention of Acute Respiratory Infection in Taiwanese Institutionalized Elderly BCG Vaccine, Placebo - Acute Respiratory Infection | Phase 2 / Phase 3 | Withdrawn | Harvard Medical School (HMS and HSDM) | 2022-05-01 | 2022-07-06 | |
| Machine Learning-Based Prediction of BCG Response in High-Risk Non-Muscle Invasive Bladder Cancer Patients Bacillus Calmette-Guerin - Non-Muscle Invasive Bladder Cancer | Unknown | Mansoura University | 100 | 2022-04-01 | 2022-04-18 | |
| A Trial to Evaluate the Effects of BCG in Adults With MCI and Mild-to-Moderate AD Biological/Vaccine: Bacillus Calmette-Guerin (BCG) - Mild Cognitive Impairment, Mild Dementia | Phase 2 | Completed | Steven E Arnold, MD | 15 | 2022-03-25 | 2025-04-13 |
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Urinary Bladder Neoplasms (26) · Non-Muscle Invasive Bladder Neoplasms (14) · COVID-19 (10) · Tuberculosis (10) · Coronavirus Infections (5) · Alzheimer Disease (3) · Colonic Neoplasms (3) · Colorectal Neoplasms (3) · Lung Neoplasms (2) · Melanoma (2) · Neoplasms (2) · Pulmonary Disease, Chronic Obstructive (2) · Recurrence (2) · Breast Neoplasms (1) · Carcinoma in Situ (1)
European Organisation for Research and Treatment of Cancer - EORTC (4) · Radboud University Medical Center (4) · Bandim Health Project (3) · Murdoch Childrens Research Institute (3) · Aeras (2) · Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (2) · Assiut University (2) · Harvard Medical School (HMS and HSDM) (2) · Ludwig Institute for Cancer Research (2) · Massachusetts General Hospital (2) · Memorial Sloan Kettering Cancer Center (2) · Merck Sharp & Dohme LLC (2) · National Institute of Allergy and Infectious Diseases (NIAID) (2) · Tuberculosis Research Centre, India (2) · University of Campinas, Brazil (2)
United States (27) · United Kingdom (14) · Netherlands (13) · Australia (11) · Canada (8) · Italy (8) · Belgium (7) · Spain (7) · Brazil (6) · France (6) · Germany (5) · Austria (4) · China (4) · Denmark (4) · Greece (4)
Giuseppe Giaccone, MD, PhD (2) · Leonardo O Reis, MD, PhD (2) · Mihai Netea, Prof. Dr. (2) · Wei Lu, Master (2) · Abraham Stein, MD (1) · Ahmed M Eltaher, professor (1) · Aishwarya Venkataraman, MRCPCH (1) · Aldo V. Bono, MD (1) · Alexandre R Zlotta, MD, PhD, FRCSC (1) · Ami Sidi, MD (1) · Amillal Bhat, MD (1) · Amnon Zisman, MD (1) · Anant Mohan (1)
PMID 16389183, PMID 42393277, PMID 10026920, PMID 15292384, PMID 16192577, PMID 18676140, PMID 18833002, PMID 21156335, PMID 21163569, PMID 22932804, PMID 23141049, PMID 23910233, PMID 25883989, PMID 26210894, PMID 26450421, PMID 26845426, PMID 27060379, PMID 27123570, PMID 27322481, PMID 27394195, PMID 27429204, PMID 27443836, PMID 28774269, PMID 29552014, PMID 30791143, PMID 30919883, PMID 31843845, PMID 32065303, PMID 32162533, PMID 32503602, PMID 32544459, PMID 3276901, PMID 32934758, PMID 34021314, PMID 34309859, PMID 34711598, PMID 35170523, PMID 35247264, PMID 35599154, PMID 35738969, PMID 36803840, PMID 36841502, PMID 36875134, PMID 37099341, PMID 37400353, PMID 37622649, PMID 37719417, PMID 37743116, PMID 37794431, PMID 38019956
2017 (3), 2018 (1), 2023 (1), 5UM1AI148684-03 (1), P30CA008748 (1), U10CA180820 (1), UM1AI068616 (1), UM1AI068632 (1), UM1AI106716 (1)