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

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.

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.