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

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis
• Intervention / Treatment: Diagnostic test: Recombinant tuberculosis allergen (RTA)

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • National Medical Research Center of Phthisiopulmonology and Infectious Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 26 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Signed informed consent for the participation in the study.
2. Age 18 to 30 years
3. A history of BCG vaccination (confirmed by medical documentation and/or the presence of BCG scar)
4. Healthy individual according to physical examination and medical records at screening.
5. Willingness to cooperate and follow the recommendations of the Investigator in accordance with the Protocol.

Exclusion Criteria:

1. A history of tuberculosis or close contact with a patient with active tuberculosis for 5 years prior to the enrollment in the study.
2. Positive T-SPOT.TB test at the enrollment in the study
3. Treatment with drugs affecting immune system within 3 months prior to the enrollment in the study
4. Vaccination against any infections <1.5 months prior to the enrollment in the study
5. Vaccination with BCG <6 months prior to the enrollment in the study.
6. The Mantoux test with 2 TU and/or the test with the recombinant tuberculosis allergen was performed less than 6 months prior to the enrollment in the study.
7. Congenital or acquired immunodeficiency.
8. Active disease of the immune system
9. HIV infection.
10. The current condition of the skin interferes with the conduct and reading of skin tests (trauma, skin diseases).
11. A disease in which blood sampling poses a risk to the volunteer (hemophilia, other bleeding disorders) or obstructed venous access.
12. The volunteer currently participates in another clinical study or has participated in another clinical study within 3 months prior to the enrollment in the study.
13. Previous participation in clinical studies of ESAT-6 and/or CFP-10 antigens.
14. Pregnancy, lactation, pregnancy planning.
15. The reluctance of a female person to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptives during the study.
16. History of alcohol, drug, benzodiazepine, or other substance abuse within the 12 months prior to the enrollment in the study.
17. Use of alcoholic beverages within 24 hours prior to the visit.
18. A condition or disease that, in the opinion of the Investigator, is inappropriate for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recombinant tuberculosis allergen (CFP10-ESAT6); RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm	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; Other Names: Diaskintest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	hour 72

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Day 28

Collaborators and Investigators

• Sponsor: National Medical Research Center of Phthisiopulmonology and Infectious Diseases
• Investigators: Principal Investigator: Aleksey V. Kazakov, MD, National Medical Research Center of Phthisiopulmonology and Infectious Diseases; Study Chair: Anastasia G. Samoylova, MD, National Medical Research Center of Phthisiopulmonologyand Infectious Diseases; Study Chair: Valentina A. Aksyonova, Prof., National Medical Research Center of Phtisiopulmonology and Infectious Diseases

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Actual): January 18, 2022
• Study Completion (Actual): January 26, 2022

Study Registration Dates

• First Submitted: January 9, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Tuberculosis; TB diagnosis; Tuberculosis skin test; CFP10; ESAT6
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: 102/1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No