The Indian Council of Medical Research (ICMR) has launched clinical trials for vaccines that prevent the spread of tuberculosis (TB) — even with close contacts to patients suffering from the disease.
The Asian country has recorded the highest number of tuberculosis patients in the world with 2.9 million new cases of the disease reported annually while 420,000 people die from it within the same time frame.
The resurgence of efforts at ameliorating the plight of Indians with respect to TB comes after similar trials had been carried out several decades ago.
ICMR said two potential candidates — VPM 1002 and MIP (mycrobacterium indicus pranii) — have been shortlisted for going through phase III vaccine trials in healthy contacts of TB patients.
“Of the two, VPM1002 is being produced by the Serum Institute of India, Pune. VPM1002 is a live recombinant form of BCG that has been developed by Vakzine Projekt Management, Germany and has been licensed to Serum Institute of India,” it said.
According to the researchers, the trial will evaluate the safety and efficacy of the two vaccines against a control group with no vaccine and would enroll 12,000 household contacts of TB that have reported a high risk of contracting the disease.
ICMR said that the trial has obtained approval from statutory regulatory bodies in India and would recruit its contacts from seven sites in six states which would span Delhi, Karnataka, Maharashtra, Orissa, Tamil Nadu, and Telangana.
“Clinical trials are needed in India to show that the vaccine is safe and effective, and can provide protection to Indian populations where the disease is endemic,” said Balram Bhargava, ICMR director general.
“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.”
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