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

Primary Purpose

Tuberculosis

Status

Completed

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Recombinant tuberculosis allergen (RTA)

About this trial

This is an interventional diagnostic trial for Tuberculosis focused on measuring Tuberculosis, TB diagnosis, Tuberculosis skin test, CFP10, ESAT6

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
History of alcohol, drug, benzodiazepine, or other substance abuse within the 12 months prior to the enrollment in the study.
Use of alcoholic beverages within 24 hours prior to the visit.
A condition or disease that, in the opinion of the Investigator, is inappropriate for participation in the study.

Sites / Locations

National Medical Research Center of Phthisiopulmonology and Infectious Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recombinant tuberculosis allergen (CFP10-ESAT6)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT05203068

First Posted

January 9, 2022

Last Updated

October 11, 2022

Sponsor

National Medical Research Center of Phthisiopulmonology and Infectious Diseases

1. Study Identification

Unique Protocol Identification Number

NCT05203068

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

November 24, 2021 (Actual)

Primary Completion Date

January 18, 2022 (Actual)

Study Completion Date

January 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Medical Research Center of Phthisiopulmonology and Infectious Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis

Keywords

Tuberculosis, TB diagnosis, Tuberculosis skin test, CFP10, ESAT6

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Recombinant tuberculosis allergen (CFP10-ESAT6)

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Recombinant tuberculosis allergen (RTA)

Other Intervention Name(s)

Diaskintest

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of the Volunteers With the True Negative RTA Result

Description

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

Secondary Outcome Measure Information:

Title

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

Description

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

Title

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

Description

Time Frame

Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. History of alcohol, drug, benzodiazepine, or other substance abuse within the 12 months prior to the enrollment in the study. Use of alcoholic beverages within 24 hours prior to the visit. A condition or disease that, in the opinion of the Investigator, is inappropriate for participation in the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aleksey V. Kazakov, MD

Organizational Affiliation

National Medical Research Center of Phthisiopulmonology and Infectious Diseases

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anastasia G. Samoylova, MD

Organizational Affiliation

National Medical Research Center of Phthisiopulmonologyand Infectious Diseases

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Valentina A. Aksyonova, Prof.

Organizational Affiliation

National Medical Research Center of Phtisiopulmonology and Infectious Diseases

Official's Role

Study Chair

Facility Information:

Facility Name

National Medical Research Center of Phthisiopulmonology and Infectious Diseases

City

Moscow

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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