- India may introduce a vaccine against tuberculosis two years later
- The registration of 12,000 participants aged six years and older for the trial has been completed
- ICMR-NARI is the main site and it has completed the registration of 1,593 healthy household contacts
India may come up with a tuberculosis vaccine two years later, with the Phase 3 clinical trials of two candidates due in 2024.
Dr Suchit Kamble, a researcher at the ICMR-National AIDS Research Institute (NARI) in Pune, informed us that trials are underway to evaluate the efficacy and safety of two TB vaccine candidates – VPM1002 and Immunovac – to prevent tuberculosis in healthy household contacts with newly diagnosed sputum-positive pulmonary TB patients. New tuberculosis vaccines are needed immediately to achieve India’s goal of eliminating tuberculosis by 2025.
A Phase-3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of VPM1002 and Immunovac vaccines for the prevention of tuberculosis is being held at 18 locations in six states – Maharashtra, Delhi, Telangana, Tamil Nadu, Karnataka and Odisha, “Kamble told PTI.
The registration of 12,000 participants aged six years and older for the trial has been completed and their follow-up will continue until 2024.
ICMR-NARI is the capital of Maharashtra and has completed the registration of 1,593 healthy household contacts. These participants are followed up at regular intervals over 38 months. The last follow-up to the Pune site is expected to be completed in February 2024.
“After analyzing the data, based on scientific evidence, we draw conclusions regarding the efficacy and safety of these vaccines. We hope that India will have a good, effective vaccine against tuberculosis by 2024 or at most 2025,” Kamble said.
The risk of TB transmission to household contacts is slightly greater when the case in the family is sputum-positive. The BCG vaccine is currently used in children at birth. The trial is sponsored by the Indian Council of Medical Research (ICMR).
“ICMR-NARI is working on various fronts to help India’s goal of eliminating tuberculosis. This includes treatment trials for multi-resistant tuberculosis and tuberculosis vaccine trials,” said National Institute of Virology (NIV) Director Dr Priya Abraham.
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