NCT05945498

Evaluation of ТВ/Flu-05Е Vaccine for the Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50 Years

Randomized, Double-blind, Placebo-controlled Phase 1 Trial of ТВ/Flu-05Е Intranasal Vector Vaccine for the Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Tatyana Zubkova · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to investigate safety, reactogenicity and immunogenicity 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 include 51 participants in two cohorts. At the first stage, 15 volunteers (Cohort 1), randomized in a 2:1 ratio (10 people in the vaccine group and 5 people in the placebo group) will be included in the study. At the second stage, the following 36 people (Cohort 2) will be included in the study, which will be randomly distributed (randomization) in a ratio of 2: 1 for the vaccine preparation (24 people) and placebo (12 people). Duration of the study for each participant is about 4 months (no more than 122 days).

Conditions

• Tuberculosis Infection

Interventions

Type	Name	Description
BIOLOGICAL	TB/Flu-05E vaccine	Participants will receive single intranasal injection of A/H1N1pdm09 recombinant attenuated influenza vector (7.7 lg EID50) with modified NS gene coding for the TB10.4 and HspX antigens of M. tuberculosis
BIOLOGICAL	Placebo	Participants will receive single intranasal injection of placebo buffer solution

Timeline

• Start date: 2023-05-10
• Primary completion: 2023-06-16
• Completion: 2023-09-18
• First posted: 2023-07-14
• Last updated: 2024-04-18

Locations

1 site across 1 country: Russia