Title: “A multicenter phase II/III double-blind, randomized, Placebo controlled study to evaluate the efficacy and safety of VPM1002 in the prevention of Tuberculosis (TB) recurrence in Pulmonary TB patients after successful TB treatment in India” is ongoing at KEMHRC, Vadu.

Sponsor: Serum Institute of India Limited (SIIL)

Objective: The objective of the study is to evaluate the efficacy of VPM1002 in prevention of TB recurrence in former pulmonary TB patients who have successfully completed ATT and were declared cured. The secondary objective of this study is to evaluate the safety of VPM1002. It is estimated that about 40% of the Indian population is infected with TB bacteria, the vast majority of whom have latent rather than active TB disease, estimated by the WHO that 220,000 people die from TB each year in India. Bacille Calmette-Guerin vaccine (BCG), an attenuated strain of M. bovis, given at birth has been in use as a TB vaccine since 1921. It is used in routine expanded programme of immunization (EPI) across the world. Since BCG clearly has inadequate efficacy against adult TB. This research, and its implementation in high burden TB settings, has been prioritized by the World Health Organization’s Stop TB Partnership in their updated Global Research Plan for TB. The Sponsor has pioneered an innovative recombinant BCG vaccine namely, VPM1002, that has shown promise as a primary and secondary prevention strategy by vaccination against TB.


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