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Mycobacterium Vaccae for Injection
Mycobacterium vaccae is an inactivated whole-cell vaccine that stimulates the immune system to enhance Th1-mediated cellular immunity against tuberculosis and other mycobacterial infections.
Mycobacterium vaccae is an inactivated whole-cell vaccine that stimulates immune responses to enhance anti-tuberculosis immunity and potentially modulate Th1/Th2 balance. Used for Tuberculosis (adjunctive immunotherapy in combination with standard anti-TB chemotherapy), Pulmonary tuberculosis.
At a glance
| Generic name | Mycobacterium Vaccae for Injection |
|---|---|
| Sponsor | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
| Drug class | Immunotherapeutic vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains heat-inactivated Mycobacterium vaccae, a non-pathogenic mycobacterium that primes dendritic cells and T cells to shift the immune response toward a Th1 phenotype, enhancing cell-mediated immunity. This approach is designed to boost protective immune responses in patients with tuberculosis or to provide adjunctive immunotherapy in combination with standard anti-TB drugs. The mechanism relies on pattern recognition receptors and mycobacterial antigens to activate innate and adaptive immunity.
Approved indications
- Tuberculosis (adjunctive immunotherapy in combination with standard anti-TB chemotherapy)
- Mycobacterial infections
Common side effects
- Local injection site reactions (erythema, induration, pain)
- Fever
- Fatigue
- Headache
Key clinical trials
- Clinical Trial of Mica (PHASE4)
- Phase III Clinical Study of Efficacy and Safety of Vaccae™ to Prevent Tuberculosis (PHASE3)
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 |
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