N/A
N=150
Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT05203068 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Number of the Volunteers With the True Negative RTA Result — 145; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Recombinant tuberculosis allergen (RTA) (Diagnostic_test)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Medical Research Center of Phthisiopulmonology and Infectious Diseases
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of the Volunteers With the True Negative RTA Result |
145; 5 | — |
| SECONDARY Number of Subjects With Local Adverse Reactions Within 72 Hours Following the Intradermal Test Application |
— | — |
| SECONDARY Number of Participants With General and Local Adverse Reactions Within 28 Days After Administration of RTA |
1; 0; 149 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05203068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.