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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm
National Medical Research Center of Phthisiopulmonology and Infectious Diseases
Moscow, Russia
Number of the Volunteers With the True Negative RTA Result
Absolute number and percentage of the volunteers with negative and positive test results with RTA based on the results of the assessment of the infiltrate 72 hours after the test application
Time frame: hour 72
Number of Subjects With Local Adverse Reactions Within 72 Hours Following the Intradermal Test Application
To assess the number of subjects who developed the injection site adverse reaction (redness, swelling etc) within 72 hours after RTA test application
Time frame: hour 72
Number of Participants With General and Local Adverse Reactions Within 28 Days After Administration of RTA
To assess the number of subjects who developed the general adverse reaction (e.g. infections, fever, headache, weakness etc) based on the subjects complaints and physical examination, and local injection site reaction (redness, swelling etc) up to 28 days after intradermal RTA application.
Time frame: Day 28
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