India is home to 1/4th of the world’s tuberculosis burden, which has given the country an opportunity to make huge strides in public health by becoming a global leader in tuberculosis research. Taking this initiative, a vaccine trial was launched on 15th of July 2019 by the Indian Council of Medical Research (ICMR), to prevent occurrence of tuberculosis among close contacts of a tuberculosis patient who are at high risk of contracting the disease.
The new vaccine – Phase-III trials
The most famous BCG vaccine trial had been undertaken decades ago, after which a Phase-III trial is being conducted now for this new vaccine, to come up with the first tuberculosis vaccine for adults, as the BCG vaccine available and tested is only for newborns. This step is a stride towards prevention, which will help in decreasing the burden of the tuberculosis disease. After a detailed landscape analysis of the available lead vaccine candidates, two potential vaccine candidates VPM 1002 and MIP were shortlisted for being taken forward through the Phase-III trial in healthy household contacts of sputum smear positive tuberculosis patient. This clinical trial will evaluate the safety and efficacy of these two vaccines in a single trial, against a control group with no vaccine. The study would enroll 12,000 healthy household contacts of sputum smear positive tuberculosis cases that are at high risk of contracting the disease. These contacts would be from 7 sites in 6 states, namely Delhi, Orissa, Tamil Nadu, Karnataka, Maharashtra, and Telangana. The trial has begun at the first site, and will subsequently be initiated at other sites too, with a goal to complete the enrollment within 7-8 months.
What experts said
- Balram Bhargava, Secretary at the Department of Health Research and Director General at ICMR, appreciated the Government’s support and researchers involved in the trial, at the launch of the vaccine’s clinical trial. He said that the clinical trials are needed in India to prove that the vaccine is safe and effective, and can provide protection to Indian populations, where the disease is endemic. The ultimate goal of this trial is to develop a vaccine that can prevent active tuberculosis and be a part of large campaigns aimed at eliminating the disease. The clinical study can thus help in achieving this goal and significantly advance the global fight against tuberculosis.
- Rohit Sarin, Director at NITRD, said that this trial is a much awaited one, which is why he promised to provide complete support in timely completion of the procedure. In fact, every statutory regulatory body of India has approved this trial, as per the Indian regulatory guidelines.
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