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

NCT04975737 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9500

Last updated 2026-07-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

GamTBvac

The subunit recombinant tuberculosis vaccine GamTBvac (lyophilisate for preparation of solution for subcutaneous administration, 5.35 mg / dose)

BIOLOGICAL

Placebo

Placebo for subcutaneous administration

Sponsors & Collaborators

  • Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Russia

Study Locations

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Entities

Drugs
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 NCT04975737 on ClinicalTrials.gov