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BCG vaccine (Freeze-dried)
BCG vaccine stimulates the immune system to recognize and attack Mycobacterium tuberculosis by activating T-cell and macrophage-mediated immunity.
BCG vaccine stimulates the immune system to recognize and attack Mycobacterium tuberculosis by activating T-cell and macrophage-mediated immunity. Used for Tuberculosis prevention (primary indication), Bladder cancer (intravesical BCG therapy).
At a glance
| Generic name | BCG vaccine (Freeze-dried) |
|---|---|
| Sponsor | Tuberculosis Research Centre, India |
| Drug class | Live attenuated vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
BCG (Bacillus Calmette-Guérin) is a live attenuated strain of Mycobacterium bovis that primes both cellular and innate immune responses against tuberculosis. The vaccine induces CD4+ and CD8+ T-cell responses and activates macrophages to control intracellular mycobacterial infection. It also provides non-specific immunological benefits through trained immunity mechanisms.
Approved indications
- Tuberculosis prevention (primary indication)
- Bladder cancer (intravesical BCG therapy)
Common side effects
- Local reaction at injection site (erythema, induration)
- Fever
- Lymphadenitis (regional lymph node enlargement)
- Disseminated BCG infection (rare, immunocompromised)
Key clinical trials
- Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC) (PHASE3)
- Evaluating the Safety and Immunogenicity of MTBVAC (PHASE2)
- Immunization With BCG Vaccine to Prevent Tuberculosis Infection (PHASE3)
- Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST) (PHASE2)
- Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024) (PHASE2)
- BCG Vaccination to Protect Healthcare Workers Against COVID-19 (PHASE3)
- Measles and BCG Vaccines for Mother and Child (PHASE4)
- A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02) (PHASE2)
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 |