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

NCT05203068 | Completed Results

• 1 other identifier: 102/1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

Tuberculosis; TB diagnosis; Tuberculosis skin test; CFP10; ESAT6

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Subjects With Local Adverse Reactions Within 72 Hours Following the Intradermal Test Application

  hour 72

• Number of Participants With General and Local Adverse Reactions Within 28 Days After Administration of RTA

  Day 28

Study Arms (1)

Recombinant tuberculosis allergen (CFP10-ESAT6)

EXPERIMENTAL

RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm

Diagnostic Test: Recombinant tuberculosis allergen (RTA)

Interventions

Recombinant tuberculosis allergen (RTA) DIAGNOSTIC_TEST

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

Also known as: Diaskintest

Recombinant tuberculosis allergen (CFP10-ESAT6)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• A history of tuberculosis or close contact with a patient with active tuberculosis for 5 years prior to the enrollment in the study.
• Positive T-SPOT.TB test at the enrollment in the study
• Treatment with drugs affecting immune system within 3 months prior to the enrollment in the study
• Vaccination against any infections \<1.5 months prior to the enrollment in the study
• Vaccination with BCG \<6 months prior to the enrollment in the study.
• 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.
• Congenital or acquired immunodeficiency.
• Active disease of the immune system
• HIV infection.
• The current condition of the skin interferes with the conduct and reading of skin tests (trauma, skin diseases).
• A disease in which blood sampling poses a risk to the volunteer (hemophilia, other bleeding disorders) or obstructed venous access.
• 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.
• Previous participation in clinical studies of ESAT-6 and/or CFP-10 antigens.
• Pregnancy, lactation, pregnancy planning.
• The reluctance of a female person to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptives during the study.

Sponsors & Collaborators

• National Medical Research Center of Phthisiopulmonology and Infectious Diseases: lead

Study Sites (1)

National Medical Research Center of Phthisiopulmonology and Infectious Diseases

Moscow, Russia

Location

Related Publications (1)

• Vasilyeva IA, Aksenova VA, Kazakov AV, Kiseleva YY, Maryandyshev AO, Dolzhenko EN, Abramchenko AV, Klevno NI, Glebov KA, Panova AE, Petrova LY, Sheikis EG, Seregina IV, Nikishova EI, Doktorova NP, Samoilova AG. Evaluation of the specificity of an intradermal test with recombinant tuberculosis allergen in Bacillus Calmette-Guerin-vaccinated healthy volunteers. Front Med (Lausanne). 2023 Mar 1;10:1042461. doi: 10.3389/fmed.2023.1042461. eCollection 2023.

  PMID: 36936243 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Dr. Kazakov Aleksey Vladimirovich, principal investigator
• Organization: Federal State Budgetary Institution "National Medical Research Center of Phthisiopulmonology and Infectious Diseases" of the Ministry of Health of the Russian Federation

alexeykazakov1982@yandex.ru

+79254666638

Study Officials

• Aleksey V. Kazakov, MD

  National Medical Research Center of Phthisiopulmonology and Infectious Diseases

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: January 24, 2022
• Study Start: November 24, 2021
• Primary Completion: January 18, 2022
• Study Completion: January 26, 2022
• Last Updated: August 25, 2023
• Results First Posted: August 25, 2023

Record last verified: 2022-10

Locations

RU (1)