Recombinant Mycobacterium Tuberculosis Fusion Protein(EEC)(Chengdu Coen Biotechnology)

This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety and preliminary efficacy of EEC in the population aged 3 to 75 years old.
In the first stage,180 healthy subjects, 140 tuberculosis（TB）subjects and 40 non-TB subjects with lung diseases aged 18 to 65 years old are divided into different groups through a randomized, blind methods. Every group carry out a low-dose (2.5μg/ml) or high-dose (5μg/ml) study, with 180 subjects in each dose group .Every subject injects intradermally EEC and EC randomly in both arms of the same person. Evaluate the consistency of assay results of EEC, EC and Interferon-Gamma Release Assay（IGRA）.Evaluate the sensitivity, specificity and consistency of assay results of EEC, EC and IGRA in healthy people, TB patients and non-TB patients with lung diseases, and determine the optimal dose of EEC for clinical auxiliary diagnosis of tuberculosis.
In the second stage, 60 healthy subjects and TB subjects aged 3-17 years and 66-75 years old are divided into different groups through a randomized, open, single-arm method with the target dose. Evaluate the safety, tolerance and preliminary efficacy of target dose of EEC in healthy people and TB patients aged 3 to 17 years old and 66 to 75 years old.

主要目的： 1) 评价不同剂量重组结核杆菌融合蛋白（EEC）在18~65岁健康人群中的安全性和耐受性； 2) 评价不同剂量重组结核杆菌融合蛋白（EEC）在18~65岁肺结核病患者人群中的安全性和耐受性。 次要目的： 1) 分别在健康人群和肺结核病患者中，评价不同剂量EEC皮试结果和γ干扰素释放试验（Interferon Gamma Release Assay，IGRA）检测结果的相关性； 2) 皮试前后对健康人群和肺结核病患者进行IGRA检测，评价EEC对IGRA检测结果的影响。 3) 综合不同剂量EEC的安全性和有效性初步确定下一阶段临床研究使用的EEC剂量。