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ICMR Launches Large-Scale BCG Vaccine Trial in Adults for TB Control

  • ICMR is conducting a major clinical trial testing BCG vaccine in vulnerable adult populations, with approximately 100 million people receiving the vaccine as part of the study.

  • The trial specifically targets high-risk groups including diabetics, elderly individuals, and TB patient contacts, with results expected within one year.

  • India aims to eliminate tuberculosis by 2025 despite a two-year setback due to COVID-19, while continuing to evaluate multiple vaccine candidates including a Spanish-developed vaccine in collaboration with Bharat Biotech.

The Indian Council for Medical Research (ICMR) has launched an ambitious clinical trial evaluating the effectiveness of the Bacillus Calmette-Guérin (BCG) vaccine in controlling tuberculosis among vulnerable adult populations, marking a significant step in India's TB elimination efforts.
ICMR Chief and Health Research Secretary Rajiv Bahl revealed that the study has enrolled approximately one crore (10 million) participants in the vaccinated arm, focusing on high-risk groups including individuals with diabetes, elderly populations, and contacts of TB patients. The two-arm trial compares outcomes between vaccinated and non-vaccinated vulnerable populations.
"We will be able to determine if vaccinated individuals show any reduction in TB incidence compared to the unvaccinated group within about a year," Bahl explained. This large-scale evaluation represents a novel approach to utilizing the BCG vaccine, which is traditionally administered only to children in TB-endemic regions.

Previous Studies and Alternative Candidates

Earlier attempts to control TB through vaccination have shown mixed results. A previous study testing a recombinant BCG vaccine specifically in TB patient contacts did not demonstrate significant efficacy, according to Bahl.
The ICMR is simultaneously exploring multiple vaccine candidates. A promising collaboration between Bharat Biotech and a Spanish firm is underway, with technology transfer arrangements in place for an innovative TB vaccine. "Our condition is to make the TB vaccine in India," Bahl emphasized, highlighting the focus on domestic manufacturing capabilities.

India's TB Elimination Timeline

Union Health Minister JP Nadda acknowledged that while India maintains its commitment to eliminating TB by 2025 - five years ahead of the UN's 2030 target - the COVID-19 pandemic has caused a two-year delay in these efforts. This setback underscores the urgency of developing effective preventive measures.
The stakes are particularly high for India, which bears approximately 25% of the global TB burden. The current BCG trial represents a crucial component of the country's comprehensive strategy to combat tuberculosis, potentially offering new tools for disease prevention in vulnerable populations.
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Reference News

[1]
ICMR testing BCG vaccine for tuberculosis
tribuneindia.com · Jan 29, 2025
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