MedTrace Logo

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

NCT04975737 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7180

Last updated 2022-11-30

No results posted yet for this study

Summary

This is a multicenter, double-blind, randomized (in 1:1 ratio) placebo-controlled study to assess the safety and protective efficacy of the subunit recombinant tuberculosis vaccine GamTBvac against the development of respiratory tuberculosis not associated with HIV infection in volunteers aged 18-45 years.

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
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Russia

Study Locations

More Related Trials

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