Tuberculosis Vaccine in Healthy Indian Adults

Summary

An Open-labelled, Phase I Clinical Trial to Assess the Safety, Reactogenicity, Tolerability, and Immunogenicity of MTBVAC in healthy Indian adult volunteers A total of 30 subjects with Quantiferon®-TB Gold Plus assay negative and ages 18 to 65 years will be enrolled in this trial. All the subjects will receive a single dose of MTBVAC via the intradermal route in the right deltoid region. DSMB meetings will be conducted after Day 28 , Day 90 \& Day 180 after vaccinating all subjects.

Timeline

Start

2024-01-19

Primary completion

2024-01-29

Completion

2024-07-27

Drugs

Indications