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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.

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Site details revised at 16 of 16 sites
    v6
  2. Trial sites expanded: 1 → 16 locationsv5
  3. Primary endpoint revisedv4 Show 6 more changesShow less
    • Enrollment target: 4300 to 5500
    • Secondary endpoints: 11 to 13
    • Study description expanded, about 115 words
    • Study site revised
    • Eligibility criteria shortened, about 2 words
    • Study title shortened, about 2 words
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2024 to Feb 19, 2025
    • Study sites: 0 to 1
    • Primary and study completion dates: Mar 2028 to Mar 31, 2028
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06272812
Lead Sponsor International AIDS Vaccine Initiative
Collaborators: Biofabri, SLU, Universidad de Zaragoza
Conditions
(from sponsor)		 Tuberculosis (TB)
Related terms Tuberculosis
Enrollment 5,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov