NCT05203068

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

Evaluation of the Specificity of Intradermal Test With Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: National Medical Research Center of Phthisiopulmonology and Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-24
• Primary completion: 2022-01-18
• Completion: 2022-01-26
• First posted: 2022-01-24
• Last updated: 2023-08-25
• Results posted: 2023-08-25

Locations

1 site across 1 country: Russia