Health

ICMR launches third phase trial for adult anti-TB vaccine

The current vaccine for TB, the BCG, is only given to neonates

 
By DTE Staff
Last Updated: Wednesday 17 July 2019
Photo: Getty Images
Photo: Getty Images Photo: Getty Images

The Indian Council of Medical Research (ICMR) on July 15, 2019 said it has launched the third-phase trials for an anti-Tuberculosis vaccine that could be administered to anybody aged six years and above. Current BCG vaccines is only for neonates.

Developing an vaccine to prevent TB among adults has been a formidable challenge, recognised by the World Health Organization (WHO).

“The BCG vaccine has not remained that efficacious and hence the need for a new vaccine,” Manjula Singh, a senior scienctist with ICMR, told Down To Earth. The first two phases of trial have shown promising results, she claimed.

“While the neonatal BCG vaccination is partially efficacious at protecting infants and young children, particularly from the most severe consequences of TB disease, it is poorly protective against pulmonary disease in adolescents and adults, and therefore at reducing Mycobacterium tuberculosis (Mtb) transmission,” according to WHO.

The WHO End TB Strategy aims at a a 95 per cent reduction in TB mortality and a 90 per cent reduction in TB incidence worldwide by 2035.

“India aims to eliminate TB by 2025. While a whole range of drugs and diagnostics are being worked upon to achieve this aim, this vaccine shall play a pivotal role in that direction,” Singh said. India has the highest TB burden in the world. 

The ICMR said two vaccine candidates, ‘VPM1002’, which is produced by the Serum Institute of India, Pune, and MIP (Mycrobacterium Indicus Pranii) are being worked upon.

The study would enroll 12,000 healthy household contacts of a patient whose sputum has tested positive for TB and are therefore at high risk of contracting the disease.

The trial would be done on patients’ contacts from seven sites: Delhi, Karnataka, Maharashtra, Odisha, Tamil Nadu and Telangana.

As to when the trial could be expected to be completed, Singh said, “Ideally it should be completed in four years. But it would depend on the fact as to how early the recruitment of the contacts for the trial is.”

She said nothing could be specified at the moment about the cost of the vaccine but as a research organisation, ICMR would pitch it to be available at highly subsidised rates in the public sector as well.

“The study has the approval of all statutory regulatory bodies of India according to Indian regulatory guidelines. The study has been started at the first site at National Institute of Tuberculosis and Respiratory Diseases, New Delhi,  on July 15 and would be subsequently initiated at other sites; the goal is to complete its enrollment within seven to eight months,” the ICMR said.

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