Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-01 @ 4:54 PM
Study NCT ID:
NCT03878004
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2019-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Clinical Trial of Safety and Immunogenicity of Recombinant Subunit Tuberculosis Vaccine GamTBvac
Sponsor:
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Organization:
Study Overview
Official Title:
A Double-blind, Randomized, Multicentre, Placebo-controlled Phase II Clinical Trial of Safety and Immunogenicity of Recombinant Subunit Tuberculosis Vaccine GamTBvac in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2019-03
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:
This is a double-blind, randomized (in 3:1 ratio -vaccine : placebo) study to assess the safety, reactogenicity and immunogenicity in healthy, BCG vaccinated adults.
Detailed Description:
Participants will be randomized in two groups (in 3:1 ratio -vaccine : placebo) to receive two doses of either GamTBvac or placebo. Subjects will be followed for 5 months after dose 1.
The primary goal of this study is to assess the immunogenicity of a tuberculosis subunit recombinant GamTBvac vaccine in a vaccination scheme with double administration to healthy volunteers.
The secondary goal of this study is the in-depth assessment of the safety and reactogenicity of the tuberculosis subunit recombinant vaccine GamTBvac when given twice to healthy volunteers.
The primary goal of this study is to assess the immunogenicity of a tuberculosis subunit recombinant GamTBvac vaccine in a vaccination scheme with double administration to healthy volunteers.
The secondary goal of this study is the in-depth assessment of the safety and reactogenicity of the tuberculosis subunit recombinant vaccine GamTBvac when given twice to healthy volunteers.
Study Oversight
Has Oversight DMC:
False
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?: