Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)

MTBVAC (BBV169) vaccine is a freeze-dried powder containing live attenuated Mycobacterium tuberculosis (M. tb), which is presented as a lyophilized product in a 10- dose vial. After reconstitution with 1.0 mL sterile water for injection, one dose (0.1mL) of vaccine contains 5 x10\^5 CFU live attenuated M. tb. One dose (0.1mL) of the MTBVAC (BBV169) vaccine is to be administered in the right deltoid region via the intradermal route.

Comparator vaccine: BCG Vaccine (TUBERVAC- Moscow strain), manufactured by Serum Institute of India, is a freeze-dried powder containing an attenuated strain of Bacillus Calmette-Guerin Mycobacterium bovis as a lyophilized product in a 10-dose vial. After reconstitution with 1.0 mL diluent (Sodium chloride) for injection, one dose (0.1mL) of BCG vaccine will be administered in the right deltoid region via the intradermal route.