Clinical trial of TB vaccine for adults begins

New Delhi Jul 16: A vaccine trial to prevent occurrence of tuberculosis among close contacts of a TB patient who are at high risk of contracting the disease was launched on Monday by Indian Council of Medical Research.

The Phase III trial is being conducted to come up with the first TB vaccine for adults as the BCG vaccine is only for newborns.

This vaccine trial is a step towards prevention and decreasing the burden of this disease, a statement by the apex health research body stated.

Since, India has the highest number of TB cases in the world, ICMR is undertaking this first TB vaccine clinical trial after the famous BCG vaccine trial undertaken decades back.

After a detailed landscape analysis of the available lead vaccine candidates, two potential vaccine candidates VPM 1002 and MIP were shortlisted for taking forward through the phase III vaccine trial in healthy household contacts of sputum smear positive TB patient, it said.

The two vaccines are — VPM1002, which is produced by Serum Institute of India, Pune and Mycrobacterium Indicus Pranii (MIP).

“This clinical trial will evaluate the safety and efficacy of these two vaccines in a single trial against control group with no vaccine,” the statement said.

The study would enroll 12,000 healthy household contacts of sputum smear positive TB cases that are at high risk of contracting the disease, from 7 sites in 6 states, Delhi, Karnataka, Maharashtra, Orissa, Tamil Nadu and Telangana.

At the launch of the clinical trial for the vaccine here, Dr Balram Bhargava, Secretary, Department of Health Research and Director General, ICMR appreciated the government’s support and the researchers involved in the trial.

He 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.

“The ultimate goal is to develop a vaccine that can prevent active TB and be a part of large campaigns aimed at eliminating the disease. This clinical study in India could help achieve this goal and significantly advance the global fight against Tuberculosis,” he said.

Dr. Rohit Sarin, Director, NITRD said that it is a much-awaited trial and promised full support in timely completion of the exercise.

The study has approval of all statutory regulatory bodies of India as per the Indian regulatory guidelines.

It has been started at the first site at NITRD here today and would be subsequently initiated at other sites; the goal is to complete its enrollment within 7 to 8 months.