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BCG vaccine (SSI)
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.
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).
At a glance
| Generic name | BCG vaccine (SSI) |
|---|---|
| Also known as | J07AN01 |
| Sponsor | Radboud University Medical Center |
| Drug class | vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
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.
Approved indications
- Tuberculosis prevention
- Bladder cancer (intravesical immunotherapy)
Common side effects
- Local reaction at injection site (erythema, induration)
- Regional lymphadenitis
- Fever
- Disseminated BCG infection (rare, in immunocompromised)
Key clinical trials
- Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection (PHASE2)
- Using BCG to Protect Senior Citizens During the COVID-19 Pandemic (PHASE3)
- BCG-induced Epigenetic Modifications in the NEXT Generation (PHASE4)
- Trial to Compare BCG-Bulgaria and BCG-Denmark (PHASE4)
- Aerosol BCG Challenge Trial in Healthy UK Adults (PHASE1)
- Using BCG Vaccine to Understand Tuberculosis Infection (NA)
- A Study of GC3107(BCG Vaccine) in Healthy Infants (PHASE3)
- Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults (PHASE4)
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:
- BCG vaccine (SSI) CI brief — competitive landscape report
- BCG vaccine (SSI) updates RSS · CI watch RSS
- Radboud University Medical Center portfolio CI