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A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.

NCT06272812 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5500

Last updated 2026-03-31

No results posted yet for this study

Summary

A Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of a candidate tuberculosis (TB) vaccine, MTBVAC, against TB disease in adolescents and adults aged 14-45 years, living in a TB endemic region.

Conditions

  • Tuberculosis (TB)

Interventions

BIOLOGICAL

MTBVAC

Vaccine Dose: MTBVAC 5x10\^5 Formulation (approximately, per standard dose): 3 - 17x10\^5 CFU Sucrose Sodium glutamate Presentation: Lyophilized pellet in vials (10 doses) Volume: 0.1 mL/dose Intradermal

BIOLOGICAL

Placebo

0.9% saline Volume: 0.1 mL/dose Intradermal

Sponsors & Collaborators

  • Biofabri, SLU

    collaborator UNKNOWN

  • Universidad de Zaragoza

    collaborator OTHER

  • International AIDS Vaccine Initiative

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-19
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Kenya
  • South Africa
  • Tanzania

Study Locations

More Related Trials

Entities

Drugs

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 NCT06272812 on ClinicalTrials.gov