protocolSection identificationModule nctId: NCT06305104, orgStudyIdInfo id: KN-EEC-II, briefTitle: 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., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-18, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Chengdu CoenBiotech Co., Ltd, class: INDUSTRY, collaborators name: Beijing Chest Hospital, Capital Medical University, collaborators name: Wuhan Institute for Tuberculosis Control, collaborators name: The Public Health Clinical Center of Chengdu, collaborators name: Xuzhou Infectious Disease Hospital, collaborators name: Jiangsu Province Centers for Disease Control and Prevention, collaborators name: Changde First People's Hospital, descriptionModule briefSummary: 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., conditionsModule conditions: Tuberculosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 420, type: ESTIMATED, armsInterventionsModule interventions name: 2.5μg/ml EEC, interventions name: 5μg/ml EEC, interventions name: 5 unit（U） EC, outcomesModule primaryOutcomes measure: Sensitivity of different doses of EEC and control EC in pulmonary tuberculosis patients aged 18 to 65 years ;, primaryOutcomes measure: specificity of different doses of EEC and control EC in healthy subjects aged 18 to 65 years and patients with non-tuberculous lung disease ;, primaryOutcomes measure: 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., secondaryOutcomes measure: Receiver operator characteristic curve(ROC) of different doses of EEC to evaluate the optimal diagnostic test cut-off value of the test drug., secondaryOutcomes measure: Area under the curve(AUC) of different doses of EEC to evaluate the optimal diagnostic test cut-off value of the test drug., secondaryOutcomes measure: In healthy people, patients with tuberculosis and patients with non-tuberculous lung diseases, the consistency rates of the three detection reagents EEC, EC and IGRA were evaluated respectively., secondaryOutcomes measure: Incidence of adverse events and serious adverse events at injection and non-injection sites，abnormal incidence of laboratory indicators and vital signs during the study period., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Chest Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 101149, country: China, contacts name: Tongqun Zhang, role: CONTACT, phone: 010-89509134, email: Zhangtongqun@sina.com, contacts name: Naihui Chu, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Wuhan Institute for Tuberculosis Control, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430000, country: China, contacts name: Min Wang, role: CONTACT, phone: 13871221841, email: whsfkyyllsc@163.com, contacts name: Juan Du, Bachelor, role: PRINCIPAL_INVESTIGATOR, contacts name: Ronghui Du, Bachelor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Changde First People's Hospital, status: RECRUITING, city: Changde, state: Hunan, zip: 415000, country: China, contacts name: Shuxiang Zhou, role: CONTACT, phone: 0736-7788890, email: 450717196@qq.com, contacts name: Tianli Wang, master, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.04638, lon: 111.6783, locations facility: Jiangsu Province Centers for Disease Control and Prevention, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 212400, country: China, contacts name: Xiaoyan Ding, role: CONTACT, phone: 025-83759406, email: ec@jscdc.cn, contacts name: Limei Zhu, master, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Xuzhou Infectious Disease Hospital, status: RECRUITING, city: Xuzhou, state: Jiangsu, country: China, contacts name: Tingting Liu, role: CONTACT, phone: 0516-68900929, email: xcyllb123@163.com, contacts name: Ruimei Zhang, Bachelor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Public health clinical center of chengdu, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610066, country: China, contacts name: Qing Yang, role: CONTACT, phone: 028-64369118, email: crbykjk@126.com, contacts name: Guihui Wu, master, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False