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

NCT ID: NCT05203068

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-24
• Study Completion Date: 2022-01-26

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.

Conditions

Tuberculosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Recombinant tuberculosis allergen (CFP10-ESAT6)

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

Group Type: EXPERIMENTAL

Recombinant tuberculosis allergen (RTA)

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Recombinant tuberculosis allergen (RTA)

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Diaskintest

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Medical Research Center of Phthisiopulmonology and Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aleksey V. Kazakov, MD

Role: PRINCIPAL_INVESTIGATOR

National Medical Research Center of Phthisiopulmonology and Infectious Diseases

Anastasia G. Samoylova, MD

Role: STUDY_CHAIR

National Medical Research Center of Phthisiopulmonologyand Infectious Diseases

Valentina A. Aksyonova, Prof.

Role: STUDY_CHAIR

National Medical Research Center of Phtisiopulmonology and Infectious Diseases

Locations

National Medical Research Center of Phthisiopulmonology and Infectious Diseases

Moscow, , Russia

Countries

Russia

References

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.

Reference Type: DERIVED

PMID: 36936243 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

102/1

Identifier Type: -

Identifier Source: org_study_id