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Bacille Calmette Guerin (BCG)
BCG is a live attenuated mycobacterial vaccine that stimulates innate and adaptive immune responses to enhance anti-tumor and anti-infectious immunity.
BCG is a live attenuated mycobacterial vaccine that stimulates innate and adaptive immune responses to enhance anti-tumor and anti-infectious immunity. Used for Tuberculosis prevention, Non-muscle invasive bladder cancer (intravesical therapy), Reduction of infectious disease mortality in low-income settings.
At a glance
| Generic name | Bacille Calmette Guerin (BCG) |
|---|---|
| Sponsor | Bandim Health Project |
| Drug class | Live attenuated vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology, Oncology, Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
BCG activates dendritic cells and macrophages through pattern recognition receptors, promoting Th1 and Th17 cell differentiation and enhancing natural killer cell activity. In bladder cancer, intravesical BCG directly stimulates local immune responses against urothelial carcinoma cells. BCG also has broader immunomodulatory effects that may enhance resistance to infections and reduce mortality from infectious diseases in vaccinated populations.
Approved indications
- Tuberculosis prevention
- Non-muscle invasive bladder cancer (intravesical therapy)
- Reduction of infectious disease mortality in low-income settings
Common side effects
- Local injection site reactions (erythema, induration)
- Fever
- Lymphadenitis
- BCG-itis (disseminated infection, rare)
- Dysuria (intravesical administration)
Key clinical trials
- Safety and Challenge Study of BCG TICE(R) Vaccination to Test Tuberculosis Immunity in Heathy Humans (PHASE1)
- Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection (PHASE2)
- Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections (PHASE2)
- A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC (PHASE1, PHASE2)
- Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS) (PHASE2)
- BCG Vaccination to Protect Healthcare Workers Against COVID-19 (PHASE3)
- Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer (PHASE1, PHASE2)
- A Controlled Human Infection Model (CHIM) With Intradermal BCG in Malawi (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bacille Calmette Guerin (BCG) CI brief — competitive landscape report
- Bacille Calmette Guerin (BCG) updates RSS · CI watch RSS
- Bandim Health Project portfolio CI