Evaluation of the Specificity of Intradermal Test With Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of the Volunteers With the True Negative RTA Result
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of the Volunteers With the True Negative RTA Result
时间窗: 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
次要结局
- Number of Subjects With Local Adverse Reactions Within 72 Hours Following the Intradermal Test Application(hour 72)
- Number of Participants With General and Local Adverse Reactions Within 28 Days After Administration of RTA(Day 28)