Clinical Trial

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

Study acronym: MTBVACph2
Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-21.
Status change: Recruiting → Active, Not Recruiting 2026-04-24
Trial Details
NCT Number NCT06997367
Lead Sponsor Bharat Biotech International Limited
Conditions Tuberculosis (TB)
Enrollment 164 participants
Start Date 2025-03-27
Primary Completion 2025-09-01 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-29