Tuberculosis
Conditions
Keywords
Tuberculosis, TB diagnosis, Tuberculosis skin test, CFP10, ESAT6
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.
Interventions
DIAGNOSTIC_TESTRecombinant tuberculosis allergen (RTA)
Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm
Sponsors
National Medical Research Center of Phthisiopulmonology and Infectious Diseases
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of the Volunteers With the True Negative RTA Result | hour 72 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Local Adverse Reactions Within 72 Hours Following the Intradermal Test Application | hour 72 | 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 | Day 28 | 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. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Recombinant Tuberculosis Allergen (CFP10-ESAT6) RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm
Recombinant tuberculosis allergen (RTA): Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm | 150 |
| Total | 150 |
Baseline characteristics
| Characteristic | Recombinant Tuberculosis Allergen (CFP10-ESAT6) | — |
|---|---|---|
| Age, Continuous | 21.5 years | — |
| BCG-vaccination history | 150 Participants | — |
| Body weight | 60 kilograms | — |
| COVID-19 vaccinated | 145 Participants | — |
| Having allergic diseases in the past | 148 Participants | — |
| Having chronic diseases | 8 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Russia | 150 participants | — |
| Sex: Female, Male Female | 122 Participants | — |
| Sex: Female, Male Male | 28 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 150 |
| other Total, other adverse events | 1 / 150 |
| serious Total, serious adverse events | 0 / 150 |
Outcome results
Primary
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
Time frame: hour 72
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Recombinant Tuberculosis Allergen (CFP10-ESAT6) | Number of the Volunteers With the True Negative RTA Result | Count RTA positive | 5 Participants |
| Recombinant Tuberculosis Allergen (CFP10-ESAT6) | Number of the Volunteers With the True Negative RTA Result | Count RTA negative | 145 Participants |
Secondary
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.
Time frame: Day 28
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Recombinant Tuberculosis Allergen (CFP10-ESAT6) | Number of Participants With General and Local Adverse Reactions Within 28 Days After Administration of RTA | Number of participants developed general adverse reaction in 28 days after RTA application | 1 Participants |
| Recombinant Tuberculosis Allergen (CFP10-ESAT6) | Number of Participants With General and Local Adverse Reactions Within 28 Days After Administration of RTA | Number of participants developed local adverse reactions in 28 days after RTA application | 0 Participants |
| Recombinant Tuberculosis Allergen (CFP10-ESAT6) | Number of Participants With General and Local Adverse Reactions Within 28 Days After Administration of RTA | Number of participants without adverse reactions in 28 days after RTA application | 149 Participants |
Secondary
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
Time frame: hour 72
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Recombinant Tuberculosis Allergen (CFP10-ESAT6) | Number of Subjects With Local Adverse Reactions Within 72 Hours Following the Intradermal Test Application | 0 Participants |