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Tuberculosis Vaccine in Healthy Indian Adults

NCT06438978 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-22

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Tuberculosis Vaccine

1. Live, attenuated Mycobacterium tuberculosis (M. tb)- MTBVAC (MTBVAC)01 strain 2. 3-17x105CFU (Per dose) Sucrose Sodium glutamate 3. Lyophilized pellet in vials (10doses) 4. 0.1 mL/dose (After reconstitution with 1 mL/vial sterilized water for injection)

Sponsors & Collaborators

  • Bharat Biotech International Limited

    lead INDUSTRY

Principal Investigators

  • Dr.V.Krishna Mohan, PhD · Bharat Biotech International Limited

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-19
Primary Completion
2024-01-29
Completion
2024-07-27

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06438978 on ClinicalTrials.gov