TB CLINICAL TRIALS (Syllabus: GS Paper 3 – Sci and Tech)

Context: Recently, the clinical trials of the novel tuberculosis vaccine MTBVAC commenced in India, representing a "giant step" forward in combatting one of the world's deadliest infectious diseases, which claims the lives of over 1.6 million people annually.

TB Clinical Trials

• Developed by: Biofabri in collaboration with the Hyderabad-based Bharat Biotech.
• Potential Advantages Over BCG: MTBVAC holds promise as a more effective and long-lasting alternative to the BCG vaccine, the only tuberculosis (TB) vaccine currently available.
• Limitations of BCG: The over-a-century-old BCG offers limited protection against pulmonary TB, the most common and transmissible form of the disease.
• Importance of Clinical Trials: Clinical trials aim to assess the safety, immunogenicity, and efficacy of MTBVAC, addressing a critical need in tuberculosis prevention.
• Global TB Burden: TB claims over 1.6 million lives annually and infects more than 10 million worldwide each year, emphasizing the urgency for effective vaccines.
• India's Role in Testing: India, with the world's highest TB burden, is a crucial testing ground for MTBVAC, reflecting the significance of its clinical trials.
• Scope of Trials: The trials will assess the vaccine's safety, immune response, and efficacy in preventing TB in adults and adolescents, catering to diverse age groups.
• Progress in Clinical Trials: The vaccine entered Phase 3 clinical trials in newborns in 2023, indicating significant advancement towards its potential deployment.
• Diversified Trial Populations: Trials in HIV-uninfected and HIV-infected adults have been initiated to assess safety and immunogenicity, with further efficacy studies planned for adolescents and adults in Sub-Saharan Africa.