TB vaccine MTBVAC gets approval for Phase 2 trials
- CDSCO has approved Bharat Biotech International’s proposal to conduct the phase II clinical trial of the Mycobacterium Tuberculosis (Live Attenuated) Vaccine.
Highlights:
- This clinical trial will assess the safety and immunogenicity in healthy adolescent and adult populations of the vaccine.
- The MTBVAC is the first vaccine against TB, derived from a human source to begin clinical trials in adults in India.
- Studying the safety, immunogenicity, and efficacy of MTBVAC in the most populated country in the world and the one with the highest number of cases of this infectious disease is key to continue advancing in this vaccine.
- Expert panel also suggested performing Molecular-based RT-PCR (Real-Time Reverse Transcription – Polymerase Chain) tests instead of Sputum AFB (Acid-Fast Bacilli) smear tests for diagnosis of TB
MTBVAC
- MTBVAC is the only vaccine against tuberculosis in clinical trials based on a genetically modified form of the pathogen isolated from humans Mycobacterium tuberculosis
- Unlike BCG, it contains all the antigens present in strains that infect humans.
- BCG [Bacillus Calmette and Guérin], is an attenuated variant of the bovine TB pathogen.
- It is more than a hundred years old and has a very limited effect on pulmonary tuberculosis
- MTBVAC is being developed for two purposes -
- More effective and potentially longer-lasting vaccine than BCG for newborn children,
- For the prevention of TB in adults and adolescents, for whom there is currently no effective vaccine
Prelims Takeaway:
- Tuberculosis