The Indian Council of Medical Research (ICMR) on Monday launched a vaccine trial to prevent occurrence of tuberculosis  among close contacts of a TB patient.

This is the first-ever government conducted vaccine trial after the BCG vaccine trial that was undertaken decades ago.

Vaccine trial

This vaccine trial is an important step in preventing and lowering the burden of this disease, said an ICMR  release.

“After a detailed landscape analysis of the available lead vaccine candidates, two potential vaccine candidates — VPM 1002 produced by Serum Institute of India in Pune and Mycobacterium Indicus Pranii (MIP) — were shortlisted for taking forward through phase-III vaccine trials in healthy household contacts of sputum-smear-positive TB patients,” the release said.

The study which will test the safety and efficacy of these two vaccines by administering them in close TB contacts as opposed to a control group of close TB contacts who will not receive the vaccine.

The study will enrol 12,000 healthy household contacts of sputum-smear-positive TB cases that are at high risk of contracting the disease, from seven sites in six States — Delhi, Karnataka, Maharashtra, Odisha, Tamil Nadu and Telangana.

Balram Bhargava, Secretary, Department of Health Research and Director-General, ICMR, said that the clinical trials are needed in India to show that the vaccine is safe and effective, and that it can provide protection to Indian populations where the disease is endemic.

Rohit Sarin, Director, National Institute of Tuberculosis and Respiratory Diseases (NITRD), said that this is the much awaited trial and promised full support in its timely completion.

The study started  at NITRD, New Delhi, on Monday and would be initiated at other sites. The ICMR aims at completing the enrolment at all sites in seven-eight months.

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