NCT04975737

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

Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of the Subunit Recombinant Tuberculosis Vaccine GamTBvac in Preventing the Development of Respiratory Tuberculosis Not Associated With HIV Infection in Volunteers Aged 18-45 Years

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,180 (estimated)
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

• Tuberculosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-01-20
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2021-07-23
• Last updated: 2022-11-30

Locations

1 site across 1 country: Russia