NCT06873282

Phase 2 Study of the ТВ/Flu-05Е Tuberculosis Vaccine

Randomized, Double-blind, Placebo-controlled Phase 2 Trial of ТВ/Flu-05Е Intranasal Vector Vaccine for the Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Research Institute of Influenza, Russia · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to investigate immunogenicity and safety of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years

Detailed description

Study includes 160 participants aged 18 to 50, randomized at 3:1 ratio, to receive single intranasal dose of TB/Flu-05E vaccine or placebo, correspondingly. Duration of the study for each participant is about 4 months (no more than 114 days).

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	TB/Flu-05E	Participants will receive single intranasal injection of TB/Flu-05E vaccine in 0.5 ml, containing 7.7 lg EID50 of A/H1N1pdm09 recombinant attenuated influenza vector with modified NS gene, encoding for the TB10.4 and HspX antigens of M. tuberculosis
OTHER	Placebo	Participants will receive single intranasal injection of physiological buffer in 0.5 ml

Timeline

• Start date: 2023-12-13
• Primary completion: 2024-01-12
• Completion: 2024-04-11
• First posted: 2025-03-12
• Last updated: 2025-03-20

Locations

3 sites across 1 country: Russia