 "tuberculosis")
India may come up with a vaccine against tuberculosis two years down the line, with the phase-3 clinical trials of two candidates set to conclude in 2024.
Dr Suchit Kamble, a scientist at the ICMR-National AIDS Research Institute (NARI) in Pune, informed that the trials are underway to evaluate the efficacy and safety of two TB vaccine candidates -- VPM1002 and Immunovac -- in preventing tuberculosis in healthy household contacts of newly-diagnosed sputum positive pulmonary TB patients.
New tuberculosis vaccines are urgently required to achieve India's goal of TB elimination by 2025.
"A phase-3, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of VPM1002 and Immunovac vaccines in preventing tuberculosis is being held at 18 sites across six states -- Maharashtra, Delhi, Telangana, Tamil Nadu, Karnataka and Odisha," Kamble told PTI.
The enrolment of 12,000 participants aged six years and above for the trial has been completed and their follow-up will continue till 2024.
ICMR-NARI is the main site in Maharashtra and it has completed the enrolment of 1,593 healthy household contacts. These participants are being followed up at regular intervals for 38 months. The last follow-up at the Pune site is expected to complete by February 2024.
"After the analysis of the data, based on scientific findings, we make conclusions regarding the efficacy and safety of these vaccines. We are hoping that India will have a good, effective vaccine against TB by 2024 or, at the most, by 2025," Kamble said.
The risk of TB transmission to household contacts is a little more when the case in the family is sputum smear positive.
"At present, there is no vaccine for the prevention of TB in household contacts except for those in HIV patients and those aged below six years," Kamble said.
Currently, the BCG vaccine is used among children at the time of birth.
The trial is being sponsored by the Indian Council of Medical Research (ICMR).
"ICMR-NARI is working on various fronts to help India's goal of TB elimination. This includes treatment trials for multi-drug resistant TB and TB vaccine trial," National Institute of Virology (NIV) Director Dr Priya Abraham said.
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