MedTrace Logo

Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers

NCT05203068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-08-25

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Recombinant tuberculosis allergen (RTA)

Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm

Sponsors & Collaborators

  • National Medical Research Center of Phthisiopulmonology and Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Aleksey V. Kazakov, MD · National Medical Research Center of Phthisiopulmonology and Infectious Diseases

  • Anastasia G. Samoylova, MD · National Medical Research Center of Phthisiopulmonologyand Infectious Diseases

  • Valentina A. Aksyonova, Prof. · National Medical Research Center of Phtisiopulmonology and Infectious Diseases

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-24
Primary Completion
2022-01-18
Completion
2022-01-26

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05203068 on ClinicalTrials.gov