The Indian Council of Medical Research (ICMR) has started a vaccine trial to prevent tuberculosis (TB) among those living close to patients suffering from the disease. The clinical trial is aimed at preventing and decreasing the burden of TB in the country.
The study will enrol more than 12,000 healthy members of households who are in contact with sputum smear-positive pulmonary TB patients, and are at high risk of contracting the disease, from seven locations across six states—Delhi, Karnataka, Maharashtra, Odisha, Tamil Nadu and Telangana, the apex research organization said in a statement on Monday.
The trial has commenced at the National Institute of TB and Respiratory Diseases (NITRD), New Delhi.
It will subsequently be rolled out in other cities, according to the statement. The process of enrolment will be completed within 7-8 months, it added.
ICMR is undertaking this trial after the Bacillus Calmette–Guérin (BCG) vaccine trial, which also treats TB, was conducted decades ago.
ICMR officials said that after a detailed analysis of available lead vaccine candidates, two potential vaccine candidates VPM 1002, produced by Serum Institute of India, Pune, and MIP (Mycrobacterium Indicus Pranii), were shortlisted for phase III vaccine trials.
“This clinical trial will evaluate the safety and efficacy of these two vaccines in a single trial against control group (not suffering from the disease). 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," said Balram Bhargava, secretary, Department of Health Research (DHR) and director general, ICMR.
“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 TB," he added.
The National Democratic Alliance (NDA) government led by Prime Minister Narendra Modi aims to eradicate TB in India by 2025.
According to the Global TB Report 2017 issued by the World Health Organization (WHO), India has the highest number of TB cases in the world.
In 2016, there were an estimated 10.4 million new TB cases worldwide.
In India, an estimated 2.79 million patients were suffering from the disease in 2016, while 423,000 patients were estimated to have died during the year.
India was also one of the major contributors to under-reporting and under-diagnosis of TB cases globally, according to the Global Tuberculosis Report 2018 released by WHO last year.
TB can easily be detected through diagnostic tests. A positive tuberculosis skin test indicates that a person might only have a TB infection and not the disease.
A positive sputum microscopy or molecular test, meanwhile, confirms a diagnosis of the disease.
Although TB is a cause for concern, a patient generally becomes non-infectious within two to three weeks with treatment.