Context:
TB Vaccine MTBVAC Phase II Trials Approved by CDSCO.
Key points:
- MTBVAC: India’s Bharat Biotech, in collaboration with Biofabri (Spain), is developing a new tuberculosis (TB) vaccine called MTBVAC.
- MTBVAC is the first tuberculosis vaccine developed from a human source and has entered clinical trials.
- It stands out from other vaccines against tuberculosis in clinical trials because it is based on a genetically modified form of the pathogen Mycobacterium tuberculosis, which was isolated from humans.
- Unlike the BCG vaccine, MTBVAC contains all the antigens present in strains of the pathogen that infect humans.
- Phase II Approval: The CDSCO Subject Expert Committee (SEC) has approved Phase II clinical trials of MTBVAC (Live Attenuated) to assess safety and immune response in healthy adolescents and adults.
Central Drugs Standard Control Organization (CDSCO)
- It functions under the Ministry of Health and Family Welfare, Government of India.
- It is the National Regulatory Authority (NRA) of India.
- Headquarter: New Delhi
- Under the Drugs and Cosmetics Act, of 1940: It oversees drug approval, and clinical trials, sets drug standards, ensures the quality of imported drugs, and coordinates with state drug control bodies to enforce uniform regulations.
Significance of MTBVAC:
- Addressing Limitations of BCG: Existing BCG vaccine (Bacillus Calmette-Guérin) is over a century old and offers limited protection against pulmonary TB, the most common form.
- Potential Advantages of MTBVAC:
- Developed from a human TB strain, potentially offering broader protection.
- Aims to be more effective and longer-lasting than BCG, especially for newborns and adults/adolescents (who currently lack an effective vaccine).
Trial Details:
- Phase II trials will assess safety and immune response in healthy adolescents and adults.
- CDSCO has suggested modifications:
- Revising exclusion criteria for participants.
- Using a more accurate TB diagnostic test (molecular-based RT-PCR) instead of Sputum AFB (Acid-Fast Bacilli) smear tests.
- Regular Data and Safety Monitoring Board (DSMB) reviews.
BCG Vaccine
- Purpose: It is the only currently available attenuated vaccine form of Mycobacterium bovis used to prevent tuberculosis and other mycobacterial infections
- History: It was developed by Calmette and Guerin and was first administered to human beings in 1921.
- Mechanism: Made from a weakened strain of bovine TB bacteria (different from human TB). It stimulates the immune system to recognize and fight TB infection.
- Limitations:
- Offers limited protection against pulmonary TB (most common form).
- Effectiveness wanes over time.
- Not recommended for everyone (e.g., immunocompromised individuals).
Other vaccines in a row
| Vaccine | Type | Stage | Target | Key Points |
| MTBVAC | Live attenuated bacteria | Phase II trials | Adults & Adolescents | First human-derived TB vaccine in clinical trials |
| M72/AS01E | Protein-subunit | Phase IIb trials | Adults with latent TB infection | Protects against progression to active TB disease |
| Viral-Vectored Vaccines (e.g., MVA85A) | Viral vector | Various stages | Children (BCG booster) | Aims to boost BCG-induced immunity |
| rBCG30 | Engineered BCG | Phase I trials | Infants | Potential for longer-lasting protection than BCG |
| VPM1002 | Recombinant BCG | Phase III trials | Newborns, Adults & Adolescents | Modified BCG expressing specific antigens for potentially broader protection |