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Study of the Safety and Efficacy of the Subunit Recombinant Tuberculosis Vaccine GamTBvac

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary and study completion dates: Nov 2025 to Dec 2026v5 Show 6 more changesShow less
    • Primary endpoints: 1 to 4
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 7180 to 9500
    • Eligibility criteria expanded, about 237 words
    • Site details revised
    • Study arms: 2 to 6
  2. Eligibility criteria expanded, about 22 wordsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2021 to Jan 20, 2022
    v3
  4. Study Status, Contacts/Locationsv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is a multicenter, double-blind, randomized, placebo-controlled Phase III trial designed to evaluate the efficacy and safety of the GamTBvac recombinant subunit tuberculosis vaccine for the prevention of active non-HIV-associated pulmonary tuberculosis. The study is divided into three stages. A total of 9,500 volunteers are planned to be enrolled in the study. Stage 1: A total of 354 volunteers with no history of pulmonary tuberculosis will be enrolled. Volunteers will be randomized in a 1:1 ratio into one of two groups receiving either GamTBvac or placebo. Within each group, stratification will be performed according to the presence or absence of a risk factor (smoking). Based on the results of this stage, the safety of the GamTBvac vaccine will be evaluated according to the criteria specified in the study objectives for Stage 1. Stage 2: A total of 2,146 volunteers with a history of active pulmonary tuberculosis that resulted in cure without residual changes or with minor residual changes, without aggravating factors, and who at the time of participation are registered and under follow-up in Dispensary Group III will be enrolled. Volunteers will be randomized in a 1:1 ratio into one of two groups receiving either GamTBvac or placebo. Based on the results of this stage, the prophylactic efficacy and safety of the GamTBvac vaccine will be evaluated according to the criteria specified in the study objectives for Stage 2. In the absence of statistically significant data on vaccine efficacy by Visit 6 (24 months ± 30 days), the study will proceed to Stage 3. In the event that statistically significant data on the prophylactic efficacy of GamTBvac are obtained by Visit 6 (24 months ± 30 days), the study will be terminated. Stage 3: Up to 7,000 volunteers with no history of active pulmonary tuberculosis will be enrolled. Volunteers will be randomized in a 1:1 ratio into one of two groups receiving either GamTBvac or placebo. Within each group, stratification will be performed according to the presence or absence of a risk factor (smoking). Based on the results of this stage, the safety and prophylactic efficacy of the GamTBvac vaccine will be evaluated according to the criteria specified in the study objectives for Stage 3.
Trial Details
NCT Number NCT04975737
Lead Sponsor Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Conditions
(from sponsor)		 Tuberculosis
Related terms Tuberculosis
Enrollment 9,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov