Clinical Trial to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old. - Trial NCT06305104
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Study Focus
Sponsor & Location
Chengdu CoenBiotech Co., Ltd
Timeline & Enrollment
Phase 2
Jul 18, 2023
Jun 30, 2024
Primary Outcome
Sensitivity of different doses of EEC and control EC in pulmonary tuberculosis patients aged 18 to 65 years ;,specificity of different doses of EEC and control EC in healthy subjects aged 18 to 65 years and patients with non-tuberculous lung disease ;,The skin test site specific reaction at 4h,8h (only for stage 2);24h, 48h, 72h, 96h, and 7 days after skin test. Those with average diameter of induration/redness is ≥5 mm will be considered to positive.
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06305104
Non-Device Trial