bacille calmette-guerin
Vaccineapproved
Approved
Jul 1, 1927
The Bacillus Calmette–Guérin (BCG) vaccine is a vaccine primarily used against tuberculosis (TB). It is named after its inventors Albert Calmette and Camille Guérin. In countries where tuberculosis or leprosy is common, one dose is recommended in healthy babies as soon after birth as possible. In areas where tuberculosis is not common, only children at high risk are typically immunized, while suspected cases of tuberculosis are individually tested for and treated. Adults who do not have tuberculosis and have not been previously immunized, but are frequently exposed, may be immunized, as well. BCG also has some effectiveness against Buruli ulcer infection and other nontuberculous mycobacterial infections. Additionally, it is often used as part of the treatment of bladder cancer. — Wikipedia
Clinical trial activity
227 trials · 312 clinical orgs · 2 marketing orgs
Phase 1
63
Phase 2
117
Phase 3
69
Phase 4
30
Earliest trial started Sep 1, 1977 (NCT00427570)
Timeline
1920s
- Jul 1, 1927
Earliest FDA Approval
1970s
- Jan 1, 1977
Earliest Phase 3 Sponsor(trial)
1980s
2000s
- Feb 24, 2000
Sanofi-Aventis — NDA Secondary Org
Indications
Approved for
Studied for
- Absenteeism · Phase 4
- Alzheimer Disease · Phase 2
- Antineoplastic Agents · Phase 1/Phase 2
- BCG Vaccine · Phase 4
- Blindness · Phase 4
- Breast Neoplasms · Phase 1
- Carcinoma in Situ · Phase 2
- Carcinoma, Transitional Cell · Phase 4
- Cognitive Dysfunction · Phase 2
- Colorectal Neoplasms · Phase 3
- Coronary Disease · Phase 4
- Coronavirus · Phase 4
- Coronavirus Infections · Phase 4
- COVID-19 · Phase 4
- COVID-19 Vaccines · Phase 2
- Dementia · Phase 2
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 1 · Phase 2
- Diarrhea · Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Eczema · Phase 3
- Endoscopy · Phase 2
- Epigenomics · Phase 4
- Epithelial Cells · Phase 2
- Fibromyalgia · Phase 2
- Fibrosis · Phase 4
- Genes, erbB-2 · Phase 2
- Healthy Volunteers · Phase 3
- Hemophilia A · Phase 3
- Hemophilia B · Phase 3
- HIV · Phase 2
- HIV Infections · Phase 2
- Hospitalization · Phase 4
- Hypersensitivity · Phase 3
- Immunity · Phase 4
- Immunity, Cellular · Phase 2
- Immunity, Heterologous · Phase 4
- Immunity, Innate · Phase 4
- Immunization · Phase 4
- Immunosenescence · Phase 3
- Immunotherapy, Active · Phase 3
- Infant · Phase 4
- Infant Death · Phase 4
- Infant Mortality · Phase 4
- Infections · Phase 4
- Influenza, Human · Phase 2/Phase 3
- Latent Tuberculosis · Phase 4
- Lung Diseases · Phase 3
- Lung Neoplasms · Phase 1/Phase 2
- Malaria · Phase 4
- Malaria, Falciparum · Early Phase 1
- Measles · Phase 4
- Melanoma · Phase 2/Phase 3
- Morbidity · Phase 4
- Mortality · Phase 4
- Mother-Child Relations · Phase 4
- Multicenter Study · Phase 3
- Multiple Sclerosis · Phase 2/Phase 3
- Mycobacterium bovis · Phase 4
- Neonatology · Phase 4
- Neoplasm Recurrence, Local · Phase 3
- Neoplasms · Phase 3
- Neoplasms by Site · Phase 3
- Oligospermia · Phase 4
- Ovarian Neoplasms · Phase 2
- Perinatal Death · Phase 4
- Plasmodium falciparum · Phase 2
- Pulmonary Disease, Chronic Obstructive · Phase 4
- Respiratory Syncytial Virus Infections · Phase 1
- Respiratory Tract Infections · Phase 4
- Risk Factors · Phase 2
- Safety · Phase 1/Phase 2
- Sepsis · Phase 3
- Severe Acute Respiratory Syndrome · Phase 3
- Small Cell Lung Carcinoma · Phase 3
- Treatment Outcome · Phase 3
- Tuberculosis · Phase 4
- Urethral Diseases · Phase 3
- Urinary Bladder Diseases · Phase 3
- Urinary Bladder Neoplasms · Phase 4
- Urogenital Neoplasms · Phase 3
- Urologic Diseases · Phase 3
- Urologic Neoplasms · Phase 3
- Vaccine-Preventable Diseases · Phase 4
- Vaccines · Phase 4
- Virus Diseases · Phase 4
- Whooping Cough · Phase 4
Mechanism of action
- Mycobacterium tuberculosisImmunity, active
Mycobacterium tuberculosis immunity, active
Approval history
- approvedJul 1, 1927
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL2108020 ↗
- WikipediaBCG vaccine ↗
- NCATS8VJE55B0VG ↗
- ChEMBLCHEMBL2108905 ↗
Also known as
- bacille calmette-guerin
- bacillus calmette-guerin live antigen, unspecified substrain
- bacillus calmette-guerin vaccine
- bcg
- bcg
- bcg
- bcg live
- bcg vaccine
- bcg vaccine
- theracys
- tice bcg
- tice bcg
- tuberculosis vaccine
- vpm1002
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07307456 | Phase 2 | Dec 8, 2025 | Changhai Hospital |
| NCT07268339 | Phase 3 | Dec 1, 2025 | The Christie NHS Foundation Trust |
| NCT06829823 | Phase 2 | Nov 30, 2025 | ImmunityBio, Inc. |
| NCT07206225 | Phase 1 | Nov 6, 2025 | Pfizer |
| NCT07182838 | Early Phase 1 (Phase 1) | Sep 12, 2025 | Medicine Invention Design, Inc, UnitedHealth Group |
| NCT06747416 | Phase 2 | Sep 2, 2025 | Alphamab Co., Ltd. |
| NCT07064863 | Phase 1/Phase 2 (Phase 2) | Aug 1, 2025 | Queen's University, Belfast |
| NCT07048496 | N/A | Jul 5, 2025 | University of Pennsylvania |
| NCT06816017 | Phase 1 | Jun 15, 2025 | Roche |
| NCT07005726 | Phase 4 | May 9, 2025 | Bandim Health Project, Radboud University, University of Southern Denmark |
| NCT06747455 | Phase 3 | Mar 20, 2025 | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
| NCT06833073 | Phase 2 | Mar 17, 2025 | Merck, Moderna Therapeutics |
| NCT06997367 | Phase 2 | Mar 1, 2025 | Bharat Biotech International Limited |
| NCT06670755 | N/A | Nov 30, 2024 | University of Oxford |
| NCT07122414 | Phase 1/Phase 2 (Phase 2) | Aug 16, 2024 | Government of China |
| NCT06569108 | Phase 3 | Apr 1, 2024 | Alphamab Co., Ltd., Anhui Province Cancer Hospital, Capital Medical University, Central South University, China Medical University, Chinese Academy of Medical Sciences, Chongqing Medical University, Hacettepe University, Henan Medical University, Henan Provincal People's Hospital, Jiangxi Provincial People's Hospital, Jiao Tong University, Jinlin University, Kunming Medical University, LanZhou University, Nanchang University, North China University of Science and Technology Affiliated Hospital, Shandong Province Qianfoshan Hospital, Sichuan University, Soochow University, Southern Medical University, Wenzhou Medical University |
| NCT06324058 | N/A | Mar 18, 2024 | Fudan University |
| NCT06178666 | N/A | Mar 1, 2024 | University of Liverpool, University of Oxford, University of Washington, Wellcome Trust |
| NCT06246851 | N/A | Feb 29, 2024 | University of Oxford |
| NCT06255964 | Phase 1/Phase 2 (Phase 2) | Feb 15, 2024 | Fudan University, SUNHO（China）BioPharmaceutical CO., Ltd. |
Showing 20 of 227 trials
Page 1 / 12
Organizations
Research & Development (312)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bandim Health Project | Government | 17 | 15 | 3 | 2002 |
| University of Oxford | Academic/Hospital | 17 | 14 | 4 | 2001 |
| Radboud University | Academic/Hospital | 16 | 7 | 4 | 2002 |
| Harvard University | Academic/Hospital | 11 | 10 | 5 | 2007 |
| University of Southern Denmark | Academic/Hospital | 10 | 1 | 2 | 2015 |
| Aeras | Academic/Hospital | 8 | 5 | 4 | 2001 |
| National Cancer Institute (NCI) | Government | 8 | 1 | 3 | 1977 |
| Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. | For profit | 7 | 7 | 2 | 2016 |
| Government of China | Government | 7 | 3 | 3 | 2016 |
| Stellenbosch University | Academic/Hospital | 7 | 1 | 3 | 2006 |
| Vakzine Projekt Management GmbH | For profit | 7 | 5 | 3 | 2008 |
| Central South University | Academic/Hospital | 6 | 1 | 3 | 2020 |
| Merck | For profit | 5 | 2 | 3 | 2017 |
| South African Tuberculosis Vaccine Initiative (SATVI) | Academic/Hospital | 5 | 0 | 3 | 2001 |
| University of London | Academic/Hospital | 5 | 2 | 2 | 1991 |
| Alphamab Co., Ltd. | For profit | 4 | 4 | 2 | 2022 |
| AstraZeneca | For profit | 4 | 2 | 3 | 2017 |
| Biofabri, S.L | For profit | 4 | 3 | 2 | 2018 |
| Cornell University | Academic/Hospital | 4 | 2 | 3 | 1998 |
| Institut Pasteur | Academic/Hospital | 4 | 0 | 1 | 2007 |
312 organizations
Page 1 / 16
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Organon | For profit | NDA2 | Jun 21, 1989 |
| Organon | For profit | NDA | Jun 21, 1989 |
| Sanofi-Aventis | For profit | NDA2 | Feb 24, 2000 |