Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-29 @ 2:38 AM
Study NCT ID:
NCT05203068
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2022-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
Sponsor:
National Medical Research Center of Phthisiopulmonology and Infectious Diseases
Organization:
Study Overview
Official Title:
Evaluation of the Specificity of Intradermal Test With Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2022-10
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 this study is to test the recombinant tuberculosis skin test in the previously BCG vaccinated healthy adults with low risk of TB development, to determine the test specificity.
Detailed Description:
Recombinant tuberculosis allergen (RTA) is a recombinant fusion protein CFP10-ESAT6 produced by the prokaryotic cell line. The test is widely used in Russian Federation and CIS countries for the latent TB diagnosis in adults and children over 8 years old. The current clinical study is a prospective, multicenter, open-label study in the cohort of healthy adults, not classified as at risk of tuberculosis, with no clinical symptoms of the disease, with a negative T-SPOT.TB test results, to evaluate the specificity of the RTA test in 72 hours following administration of the product at a dose of 0.2 μg/0.1 mL.
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?: