NCT06997367

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

A Phase II, Randomized, Double-blind Trial to Assess the Safety and Immunogenicity of MTBVAC (BBV169), With BCG Vaccine as a Comparator in Healthy Adolescent and Adult Populations

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Bharat Biotech International Limited · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Phase II trial to establish the safety, reactogenicity, and immunogenicity of the MTBVAC with a licensed BCG vaccine as a comparator in both TB naïve (QFT PLUS negative) and TB exposed (QFT PLUS positive) healthy adults and adolescents.

Detailed description

Phase II, double-blind, randomized, safety and immunogenicity trial with BCG vaccine as a comparator in 164 healthy adults and adolescents and with both positive and negative interferon gamma release assay (IGRA) test result. Objective: To evaluate the immunogenicity of MTBVAC compared to BCG in all participants using PBMC Participants meeting the inclusion and exclusion criteria will be randomized within a study cohort in a 1:1 ratio to receive a single dose of MTBVAC or BCG vaccine administered intradermally. Only HIV-negative participants will be eligible for enrolment. A total of 164 participants aged 12-65 years will be enrolled into one of two cohorts based on their based on the QFT-Plus assay results (QFT negative and QFT positive). Cohort 1 will include 82 QFT Negative participants Cohort 2 will include 82 QFT Positive participants. Study participants will be randomized in a 1:1 ratio within each cohort to receive MTBVAC (Total N=82, includes 41 QFT negative \& 41 QFT positive participants) or BCG (Total N=82, includes 41 QFT negative \& 41 QFT positive participants) Participants will be followed up for safety and Immunogenicity following vaccination via regular visits. At least 20% of the participants will be the adolescent population in each cohort in treatment and comparator arms.

Conditions

• Tuberculosis (TB)

Interventions

Type	Name	Description
BIOLOGICAL	MTBVAC	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.
BIOLOGICAL	BCG Sii	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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-04-01
• Completion: 2026-06-30
• First posted: 2025-05-30
• Last updated: 2025-05-30

Locations

2 sites across 1 country: India