Vaccine for TB prevention in contacts of Sputum positive TB patients, ICMR launches Clinical trial
The Indian Council of Medical examination today launched a vaccine trial to prevent the occurrence of TB among close contacts of a TB case patient. This clinical trial for the vaccine is an important step in prevention and decreasing the burden of this disease.
Since India has the highest number of TB cases in the world, therefore, Indian Council of Medical Research (ICMR) is undertaking this 1st TB vaccine clinical trial after the famous BCG vaccine trial was 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.
The two vaccines include VPM1002, which is produced by Serum Institute of India, Pune and the other vaccine is MIP (Mycrobacterium Indicus Pranii).
This clinical trial will evaluate the safety and efficacy of these two vaccines in a single trial against the control group with no vaccine. The study would enrol 12000 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) of the country.
At the launch of the Clinical Trial for the vaccine at NITRD, Delhi, Dr Balram Bhargava, Secretary, Department of Health Research and Director General, ICMR expressed the appreciation for the government’s support and 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 added.
Dr Rohit Sarin, Director, National Institute of TB and Respiratory Diseases(NITRD) said that TB is manifested in only 10% of people who get infected by the TB bacterium and 90 % of people escape the disease. The organism will rest inside the body and because of the body’s immune system, the organism doesn’t manifest the disease. These candidate vaccines function as an immune modulator to combat the bacterium and consequently, the number of the organism decreases to the extent that they do not cause disease. This is the much-awaited trial and he assured full support in timely completion of the trial.
The study has the approval of all statutory regulatory bodies of India as per the Indian regulatory guidelines. The study has been started at the first site at NITRD, New Delhi today and would be subsequently initiated at other sites; the goal is to complete its enrollment within 7 to 8 months.