Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05945498
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2023-06-13
Brief Title:
Evaluation of ТВFlu-05Е Vaccine for the Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50 Years
Sponsor:
Tatyana Zubkova
Organization:
Research Institute of Influenza Russia
Study Overview
Official Title:
Randomized Double-blind Placebo-controlled Phase 1 Trial of ТВFlu-05Е Intranasal Vector Vaccine for the Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to investigate safety reactogenicity and immunogenicity of the TBFlu-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 21 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None