ChiCTR2500106823 版本V1.0 版本创建时间2025/07/30 16:51:37 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500106823 

最近更新日期：

Date of Last Refreshed on：

2025-07-30 16:51:20 

注册时间：

Date of Registration：

2025-07-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

皮肤试验用结核分枝杆菌抗原(EM)在3周岁及以上人群的有效性和安全性多中心、随机、盲法III期临床试验

Public title：

A Multicenter, Randomized, Blinded, Phase III Clinical Trial on the Efficacy and Safety of Mycobacterium tuberculosis Antigen for Skin Test (EM) in Individuals Aged 3 Years and Older

注册题目简写：

English Acronym：

研究课题的正式科学名称：

皮肤试验用结核分枝杆菌抗原(EM)在3周岁及以上人群的有效性和安全性多中心、随机、盲法III期临床试验

Scientific title：

A Multicenter, Randomized, Blinded, Phase III Clinical Trial on the Efficacy and Safety of Mycobacterium tuberculosis Antigen for Skin Test (EM) in Individuals Aged 3 Years and Older

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

何秀云 

研究负责人：

初乃惠, 聂文娟; 杜鹃, 李月华 

Applicant：

Xiuyun He 

Study leader：

Naihui Chu, Wenjun Nie; Juan Du, Yuehua Li 

申请注册联系人电话：

Applicant telephone：

+86 136 6110 9930

研究负责人电话：

Study leader's telephone：

+86 10 8950 9312

申请注册联系人传真 ：

Applicant Fax：

+86 010 69739906

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

hexiuyun_309@163.com

研究负责人电子邮件：

Study leader's E-mail：

dongchu1994@sina.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

北京市昌平区生命园路29号1幢A214

研究负责人通讯地址：

中国北京市通州区北关大街9号; 中国湖北省武汉市硚口区宝丰路 28 号

Applicant address：

A214, Building 1, No. 29 Life Science Park Road, Changping District, Beijing 102206

Study leader's address：

No. 9, Beiguan Street, Tongzhou District, Beijing, China; No. 28 Baofeng Road, Qiaokou District, Wuhan City, Hubei Province, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

安博智联(苏州)生物科技有限公司

Applicant's institution：

A&B Biotechnology Limited

研究负责人所在单位：

首都医科大学附属北京胸科医院; 武汉市肺科医院(武汉市结核病防治所)

Affiliation of the Leader：

Beijing Chest Hospital, Capital Medical University; Wuhan Pulmonary Hospital (Wuhan Municipal Tuberculosis Prevention and Treatment Institute)

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

(2025)年临审-TB第(04-01)号; 〔202(5)〕年YW 第(054)号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

首都医科大学附属北京胸科医院伦理委员会；武汉市肺科医院医学伦理审查委员会

Name of the ethic committee：

Ethics Review Committee of Beijing Chest Hospital, Capital Medical University; Wuhan Pulmonary Hospital Medical Ethics Review Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2025-06-16 00:00:00

伦理委员会联系人：

张彤群；王敏

Contact Name of the ethic committee：

Tongqun Zhang; Min Wang

伦理委员会联系地址：

中国北京市通州区北关大街9号；中国湖北省武汉市硚口区宝丰路 28 号

Contact Address of the ethic committee：

No. 9, Beiguan Street, Tongzhou District, Beijing, China; No. 28 Baofeng Road, Qiaokou District, Wuhan City, Hubei Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 8950 9134

伦理委员会联系人邮箱：

Contact email of the ethic committee：

Zhangtongqun@sina.com

研究实施负责（组长）单位：

首都医科大学附属北京胸科医院， 武汉市肺科医院（武汉市结核病防治所）

Primary sponsor：

Beijing Chest Hospital, Capital Medical University, Wuhan Pulmonary Hospital (Wuhan Municipal Tuberculosis Prevention and Treatment Institute),

研究实施负责（组长）单位地址：

中国北京市通州区北关大街9号， 中国湖北省武汉市硚口区宝丰路 28 号

Primary sponsor's address：

No. 9, Beiguan Street, Tongzhou District, Beijing, China No. 28 Baofeng Road, Qiaokou District, Wuhan City, Hubei Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

苏州市

Country：

China

Province：

Jiangsu

City：

Suzhou

单位(医院)：

安博智联（苏州）生物科技有限公司

具体地址：

苏州高新区锦峰路8号2号楼510-G067室

Institution
hospital：

A&B Biotechnology Limited

Address：

Room 510-G067, Building 2, No. 8 Jinfeng Road, High-Tech Zone, Suzhou

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

Target disease：

Tuberculosis

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 III期临床试验 

Study phase：

3

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

（1）皮肤试验用结核分枝杆菌抗原(EM)用于结核病诊断有效性与安全性验证； （2）皮肤试验用结核分枝杆菌抗原(EM)用于结核分枝杆菌潜伏感染筛查有效性与安全性验证； （3）皮肤试验用结核分枝杆菌抗原(EM)鉴别结核分枝杆菌感染与卡介苗接种的效果评价； （4）对皮肤试验用结核分枝杆菌抗原(EM)的IIa期临床研究确定的诊断标准进行验证。  

Objectives of Study：

(1) Validation of the Efficacy and Safety of Mycobacterium tuberculosis Antigen (EM) for Skin Testing in the Diagnosis of Tuberculosis; (2) Validation of the Efficacy and Safety of Mycobacterium tuberculosis Antigen (EM) for Skin Testing in Screening for Latent Mycobacterium tuberculosis Infection; (3) Evaluation of the Effectiveness of Mycobacterium tuberculosis Antigen (EM) for Skin Testing in Distinguishing Between Mycobacterium tuberculosis Infection and BCG Vaccination; (4) Validation of the Diagnostic Criteria Established in the Phase IIa Clinical Study of Mycobacterium tuberculosis Antigen (EM) for Skin Testing.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

结核病受试者纳入标准 1.*年龄3周岁及以上，男女不限，本次已开始抗结核治疗的结核病患者疗程最长不超过1个月（本次开始治疗与前次治疗停药间隔大于6个月）； 2.本人/受试者监护人自愿并同意参加本试验，能遵守临床试验方案的要求参加随访并签署知情同意书； 3.根据《中华人民共和国卫生行业标准肺结核诊断标准（WS288-2017）》/《儿童肺结核诊断专家共识（2022版）》的标准（3-17周岁）确诊为肺结核的受试者； 4.根据附件一确诊为肺外结核病患者，本次已开始抗结核治疗的结核病患者疗程最长不超过1个月（本次开始治疗与前次治疗停药间隔大于6个月）。 非结核病其他呼吸道疾病患者纳入标准 1.*年龄3周岁及以上，男女不限； 2.本人/受试者监护人自愿并同意参加本试验，能遵守临床试验方案的要求参加随访并签署知情同意书； 3.经确诊患有呼吸道或其他肺部疾病，但临床医师根据患者临床表现、影像学及实验室检查可排除结核病的受试者（包括肺炎、肺癌、支气管炎、支气管扩张、非结核分枝杆菌病（Non-tuberculous Mycobacteria, NTM）、慢阻肺等）。 非结核病其他疾病患者纳入标准 1.*年龄18-64周岁，男女不限； 2.本人自愿并同意参加本试验，能遵守临床试验方案的要求参加随访并签署知情同意书； 3.经确诊患有糖尿病或者风湿免疫病，但临床医师根据患者临床表现、影像学及实验室检查可排除结核病的受试者。 社区人群入选标准 *年龄3周岁及以上，男女不限，入组当天腋下体温<37.5℃（≤14周岁）/<37.3℃（>14周岁）； 1.本人/受试者监护人自愿并同意参加本试验，能遵守临床试验方案的要求参加随访并签署知情同意书； 2.经病史询问无结核病史、结核病家族史、结核病密切接触史（指与登记的结核病患者在其确诊前3个月至开始抗结核治疗后14天内直接接触），无肺内、外结核病，无可能为结核病的呼吸道症状及全身其它部位症状。胸部影像学检查无异常或异常无临床意义者； 3.无结核病中毒临床症状（结核中毒症状是指除外咳嗽、胸痛、胸闷等局部症状外，尚有较为明显的全身症状，如乏力、午后低热、食欲不振、夜间盗汗等。女性可能有内分泌系统的紊乱，比如月经不调、闭经等）。 卡介苗/安慰剂接种入选标准 1.*年龄18-64周岁，男女不限； 2.第一次皮试左右双臂检测结果以及IGRA检测结果全阴性的人群（即EM、TB-PPD、IGRA检测结果阴性）； 3.经人类免疫缺陷病毒（HIV）抗体检测结果为阴性。 三阴人群第二次同体双臂皮试入选标准 *年龄18-64周岁，男女不限，入组当天腋下体温<37.3℃。 如果受试者不符合带星号（*）规定的标准，可以在符合此标准时重新安排访视。

Inclusion criteria

Inclusion Criteria for Tuberculosis Patients 1. *Aged 3 years and above, regardless of gender, tuberculosis patients who have already started anti-tuberculosis treatment with a maximum treatment duration of 1 month (the interval between the start of this treatment and the discontinuation of the previous treatment is more than 6 months); 2. The patient/subject’s guardian voluntarily agrees to participate in this trial, is able to comply with the requirements of the clinical trial protocol, participate in follow-ups, and sign the informed consent form; 3. Subjects diagnosed with pulmonary tuberculosis according to the standards of the "Diagnostic Criteria for Pulmonary Tuberculosis (WS288-2017)" of the Health Industry Standard of the People’s Republic of China/"Expert Consensus on the Diagnosis of Pediatric Pulmonary Tuberculosis (2022 Edition)" (for those aged 3-17 years); 4. Subjects diagnosed with extrapulmonary tuberculosis according to Annex I, who have already started anti-tuberculosis treatment with a maximum treatment duration of 1 month (the interval between the start of this treatment and the discontinuation of the previous treatment is more than 6 months). Inclusion Criteria for Patients with Other Respiratory Diseases 1. *Aged 3 years and above, regardless of gender; 2. The patient/subject’s guardian voluntarily agrees to participate in this trial, is able to comply with the requirements of the clinical trial protocol, participate in follow-ups, and sign the informed consent form; 3. Patients diagnosed with respiratory or other pulmonary diseases, but tuberculosis can be excluded by clinicians based on the patient’s clinical manifestations, imaging, and laboratory tests (including pneumonia, lung cancer, bronchitis, bronchiectasis, Non-tuberculous Mycobacteria(NTM), chronic obstructive pulmonary disease, etc.). Inclusion Criteria for Patients with Other Diseases 1. *Aged 18-64 years, regardless of gender; 2. The patient voluntarily agrees to participate in this trial, is able to comply with the requirements of the clinical trial protocol, participate in follow-ups, and sign the informed consent form; 3. Patients diagnosed with diabetes or rheumatologic and immunologic diseases, but tuberculosis can be excluded by clinicians based on the patient’s clinical manifestations, imaging, and laboratory tests. Inclusion Criteria for Community Population Aged 3 years and above, regardless of gender, with axillary temperature <37.5℃ (≤14 years old) / <37.3℃ (>14 years old) on the day of enrollment; 1. The patient/subject’s guardian voluntarily agrees to participate in this trial, is able to comply with the requirements of the clinical trial protocol, participate in follow-ups, and sign the informed consent form; 2. No history of tuberculosis, family history of tuberculosis, or close contact history with tuberculosis patients (referring to direct contact with registered tuberculosis patients within 3 months before their diagnosis and up to 14 days after the start of anti-tuberculosis treatment), no pulmonary or extrapulmonary tuberculosis, no respiratory symptoms or symptoms in other parts of the body that may be tuberculosis. No abnormalities or clinically insignificant abnormalities in chest imaging; 3. No clinical symptoms of tuberculosis intoxication (tuberculosis intoxication symptoms refer to significant systemic symptoms, excluding local symptoms such as cough, chest pain, and chest tightness, such as fatigue, low-grade fever in the afternoon, loss of appetite, night sweats, etc. Women may have endocrine system disorders, such as irregular menstruation, amenorrhea, etc.). Inclusion Criteria for BCG/Placebo Vaccination 1. *Aged 18-64 years, regardless of gender; 2. Individuals with negative results in the first skin test on both arms and IGRA test (i.e., negative results for EM, TB-PPD, and IGRA tests); 3. Negative results in human immunodeficiency virus (HIV) antibody testing. Inclusion Criteria for the Second Intracorporeal Double-Arm Skin Test in Triple-Negative Individuals Aged 18-64 years, regardless of gender, with axillary temperature <37.3℃ on the day of enrollment. If the subject does not meet the criteria marked with an asterisk (*), they can be re-scheduled for a visit when they meet the criteria.

排除标准：

1.*入组前3个月内进行过结核菌素（PPD）或同类产品试验； 2.患急性传染病（如麻疹、百日咳、流行性感冒）、广泛性皮肤病及过敏体质（对两种或以上药物或食物有过敏史者，或已知对本药组分有过敏以及疤痕体质）者； 3.*皮试前3天处于急性疾病期或处于慢性疾病急性发作期者（如患有急性疾病，可针对呼吸道及全身症状、体征；一般情况、意识、体温、呼吸频率、心率和血压等生命体征；血常规、血生化、血气分析、CRP等指标，结合目前已有治疗方案，综合评估受试者是否已趋于临床稳定期）； 4.*皮试前3天内使用了退热、镇痛和抗过敏药物（如：对乙酰氨基酚、布洛芬、氯雷他定、西替利嗪等）； 5.有惊厥、癫痫、精神病史和/或精神病家族史（直系亲属）者； 6.有已知或可疑（或有高危发生可能）的免疫功能损伤或异常者，包括： *皮试前1个月内或正在接受免疫抑制剂（包括化疗）或免疫增强剂治疗者，如长期使用全身性糖皮质激素治疗（连续2周及以上使用，剂量2mg/kg/天或20mg/天泼尼松或相当于泼尼松剂量；皮试前3天内接受任何剂量全身性糖皮质激素类药物；允许局部用药（如软膏、滴眼液、吸入剂或鼻喷剂））、胸腺肽、白介素、干扰素、香菇多糖，卡介菌多糖核酸（BCG-PSN）等； *皮试前3个月内接受免疫球蛋白制剂或血液产品或血浆提取治疗者； 研究者评估不适合参与本研究的恶性肿瘤患者； 7.*皮试前7天内接种过非活疫苗，或28天内接种过减毒活疫苗； 8.*皮试前3个月内使用过其他临床试验用药品或器械（安慰剂、体外诊断试剂或非接触人体器械除外）或在本试验期间有参加其他临床试验的计划； 9.入组前妊娠试验检测阳性、处于哺乳期或未在入选本研究前2周内采取有效的避孕措施的育龄女性（处于女性生殖器官发育成熟（月经初潮）到卵巢功能衰退（绝经）后一年内的女性），或在研究期间有生育计划不同意采取有效的避孕措施（包括：口服避孕药、注射或埋植避孕、缓释局部避孕药、激素贴剂、宫内节育器（IUD）、绝育、避免性生活、安全套（男性）、隔膜、宫颈帽等；不视为有效的避孕措施为安全期避孕法、体外射精法和紧急避孕法等）者； 10.研究者认为存在依从性差、可能影响试验评估或者其他不适合参与本研究的任何情况。 卡介苗/安慰剂接种排除标准（研究三） 具有卡介苗接种禁忌，包括：1）对卡介苗的任何成分过敏者；2）发热及急性传染病患者，包括活动性结核患者；3）严重的慢性疾病（如心、脑、血管疾病、慢性肾病）和慢性疾病的急性发作期；4）有免疫缺陷或损害者（如艾滋病患者）；5）正使用免疫抑制药物或放射治疗。 三阴人群第二次同体双臂皮试排除标准（研究三） 符合第一次同体双臂皮试任一排除标准者。 对于带星号（*）的标准，如果受试者具有该标准规定的情形，可以在不再具有这些情形时重新安排访视。

Exclusion criteria：

1. *Having undergone a tuberculin (PPD) or similar product test within the past 3 months prior to enrollment; 2. Patients with acute infectious diseases (such as measles, pertussis, influenza), widespread skin diseases, and individuals with allergic constitutions (those with a history of allergies to two or more drugs or foods, or known allergies to components of this drug group, as well as those with a history of keloid scarring); 3. *Individuals who are in the acute phase of an illness or experiencing an acute exacerbation of a chronic disease within 3 days prior to the skin test (if suffering from an acute disease, a comprehensive assessment of whether the subject has reached a clinical stable phase can be made based on respiratory and systemic symptoms and signs; general condition, consciousness, vital signs such as body temperature, respiratory rate, heart rate, and blood pressure; laboratory tests including complete blood count, biochemistry, blood gas analysis, C-reactive protein (CRP), and the current treatment regimen); 4. *Use of antipyretics, analgesics, and antiallergic drugs within 3 days prior to the skin test (such as acetaminophen, ibuprofen, loratadine, cetirizine, etc.); Individuals with a history of seizures, epilepsy, mental illness, and/or a family history of mental illness (immediate family members); 5. Individuals with known or suspected (or at high risk of developing) immune dysfunction or abnormalities, including: 6. *Individuals who have received immunosuppressive agents (including chemotherapy) or immunoenhancing agents within 1 month prior to the skin test, such as long-term systemic corticosteroid therapy (continuous use for 2 weeks or more, with a dose of 2mg/kg/day or 20mg/day prednisone or equivalent; any dose of systemic corticosteroids within 3 days prior to the skin test; topical use (such as creams, eye drops, inhalers, or nasal sprays) is allowed), thymosin, interleukin, interferon, lentinan, BCG polysaccharide nucleic acid (BCG-PSN), etc.; *Individuals who have received immunoglobulin preparations, blood products, or plasma-derived therapies within 3 months prior to the skin test; Malignant tumor patients deemed by the investigator as unsuitable to participate in this study; 7. *Individuals who have received non-live vaccines within 7 days prior to the skin test, or live attenuated vaccines within 28 days prior to the skin test; 8. *Individuals who have used other investigational drugs or devices within 3 months prior to the skin test (excluding placebo, in vitro diagnostic reagents, or non-contact devices) or who plan to participate in other clinical trials during the course of this study; 9. Women of childbearing age who test positive for pregnancy, are breastfeeding, or have not taken effective contraceptive measures within 2 weeks prior to enrollment in this study (women who are in the period from the onset of menarche to one year after menopause), or who plan to conceive during the study period and do not agree to take effective contraceptive measures (including: oral contraceptives, injectable or implanted contraceptives, slow-release local contraceptives, hormonal patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (male), diaphragms, cervical caps, etc.; methods not considered effective contraception include rhythm method, coitus interruptus, and emergency contraception); 10. Individuals whom the investigator deems to have poor compliance, may affect the evaluation of the trial, or have any other condition that makes them unsuitable to participate in this study. Exclusion Criteria for BCG/Placebo Vaccination (Study Three) Individuals with contraindications to BCG vaccination, including: Allergy to any component of BCG; Patients with fever and acute infectious diseases, including active tuberculosis; Severe chronic diseases (such as cardiovascular, cerebrovascular, and chronic kidney diseases) and acute exacerbations of chronic diseases; Individuals with immunodeficiency or immune impairment (such as patients with AIDS); Individuals currently using immunosuppressive drugs or undergoing radiation therapy. Exclusion Criteria for the Second Intracorporeal Double-Arm Skin Test in Triple-Negative Individuals (Study Three) Individuals who meet any of the exclusion criteria for the first intracorporeal double-arm skin test. For criteria marked with an asterisk (), if a subject meets the specified condition, they may be re-scheduled for a visit when they no longer meet the condition.*

研究实施时间：

Study execute time：

从 From 2025-06-26 00:00:00至 To 2026-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-08-15 00:00:00 至 To 2026-01-31 00:00:00  

干预措施：

Interventions：

组别：

EM与EC同体双臂组

样本量：

744

Group：

EM/EC Double-arm Clinical Trial Group

Sample size：

干预措施：

试验用药品均采取孟都氏法注射于前臂掌侧皮内，对于每个受试者统一为先左臂皮内注射一次试验药物或对照药品（EM/EC），观察5-10min无明显不良反应后再在右臂皮内注射一次对照药品或试验药物（EC/EM）。

干预措施代码：

Intervention：

All investigational products are injected intradermally into the volar aspect of the forearm using the Mantoux method. For every subject, the left arm is always used first: a single intradermal injection of either the test drug or the control (EM/EC) is administered. After observing the site for 5–10 min without any significant adverse reaction, a single intradermal injection of the control or the test drug (EC/EM) is then given in the right arm.

Intervention code：

组别：

EM与TB-PPD同体双臂组

样本量：

1072

Group：

EM/TB-PPD Double-arm Clinical Trial Group

Sample size：

干预措施：

试验用药品均采取孟都氏法注射于前臂掌侧皮内，对于每个受试者统一为先左臂皮内注射一次试验药物或对照药品（EM/TB-PPD），观察5-10min无明显不良反应后再在右臂皮内注射一次对照药品或试验药物（TB-PPD/EM）。

干预措施代码：

Intervention：

All investigational products are injected intradermally into the volar aspect of the forearm using the Mantoux method. For every subject, the left arm is always used first: a single intradermal injection of either the test drug or the control (EM/TB-PPD) is administered. After observing the site for 5–10 min without any significant adverse reaction, a single intradermal injection of the control or the test drug (TB-PPD/EM) is then given in the right arm.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

 武汉市 

Country：

China 

Province：

Hubei 

City：

Wuhan 

单位(医院)：

武汉市肺科医院(武汉市结核病防治所) 

单位级别：

三甲 

Institution
hospital：

Wuhan Pulmonary Hospital (Wuhan Municipal Tuberculosis Prevention and Treatment Institute)

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

 北京市 

Country：

China 

Province：

Beijing 

City：

Beijing 

单位(医院)：

首都医科大学附属北京胸科医院 

单位级别：

三甲 

Institution
hospital：

Beijing Chest Hospital, Capital Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

 武汉市 

Country：

China 

Province：

Hubei 

City：

Wuhan 

单位(医院)：

武汉市中心医院 

单位级别：

三甲 

Institution
hospital：

Wuhan Central Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

 长沙市 

Country：

China 

Province：

Hunan 

City：

Changsha 

单位(医院)：

长沙市中心医院 

单位级别：

三甲 

Institution
hospital：

Changsha Central Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河南省 

市(区县)：

 新乡市 

Country：

China 

Province：

Henan 

City：

Xinxiang 

单位(医院)：

新乡医学院第一附属医院  

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital of Xinxiang Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 安徽省 

市(区县)：

 合肥市 

Country：

China 

Province：

Anhui 

City：

Hefei 

单位(医院)：

安徽省胸科医院  

单位级别：

三甲 

Institution
hospital：

Chest Hospital of Anhui Province

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河南省 

市(区县)：

 郑州市 

Country：

China 

Province：

Henan 

City：

Zhengzhou 

单位(医院)：

河南省传染病医院 （郑州市第六人民医院） 

单位级别：

三甲 

Institution
hospital：

Henan Infectious Disease Hospital (Zhengzhou Sixth People's Hospital)

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 广西壮族自治区 

市(区县)：

 南宁市 

Country：

China 

Province：

Guangxi 

City：

Nanning 

单位(医院)：

南宁市第四人民医院 

单位级别：

三甲 

Institution
hospital：

The Fourth People's Hospital of Nanning

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河南省 

市(区县)：

 郑州市 

Country：

China 

Province：

Henan 

City：

Zhengzhou 

单位(医院)：

河南省胸科医院 

单位级别：

三甲 

Institution
hospital：

Henan Chest Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

 潍坊市 

Country：

China 

Province：

Shandong 

City：

Weifang 

单位(医院)：

潍坊市第二人民医院 

单位级别：

三甲 

Institution
hospital：

The Second People's Hospital of Weifang

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 广西壮族自治区 

市(区县)：

 柳州市 

Country：

China 

Province：

Guangxi 

City：

Liuzhou 

单位(医院)：

柳州市人民医院 

单位级别：

三甲 

Institution
hospital：

The People's Hospital of Liuzhou

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

注射部位红晕的最大横径（单位：mm）

指标类型：

主要指标

Outcome：

The maximum transverse diameters of the erythema at the injection site (unit: mm)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

注射部位红晕的最大纵径（单位：mm）

指标类型：

主要指标

Outcome：

The maximum longitudinal diameters of the erythema at the injection site (unit: mm)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

注射部位硬结的最大横径（单位：mm）

指标类型：

主要指标

Outcome：

The maximum transverse diameters of the induration at the injection site (unit: mm)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

注射部位硬结的最大纵径（单位：mm）

指标类型：

主要指标

Outcome：

The maximum longitudinal diameters of the induration at the injection site (unit: mm)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

注射部位水泡

指标类型：

主要指标

Outcome：

blister at the injection site

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

注射部位淋巴管炎

指标类型：

主要指标

Outcome：

lymphangitis at the injection site

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

注射部位坏死

指标类型：

主要指标

Outcome：

necrosis at the injection site

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

外周血结核杆菌特异抗原刺激分泌干扰素含量

指标类型：

主要指标

Outcome：

Whole blood IFN-γ release levels in response to Mycobacterium tuberculosis-specific antigens

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 3 岁 years
最大 Max age N/A 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究采用分层区组随机化法，以不同年龄层（3-17周岁、18-64周岁和65周岁及以上）为分层因素，并通过交互式网络应答随机系统（Interactive Web Response System，IWRS）将受试者按1:1比例随机分配至不同的试验组别。随机化盲底由随机化统计师产生并保存。

Randomization Procedure (please state who generates the random number sequence and by what method)：

This study is a double-arm intracorporeal trial, employing a randomized, blinded, and controlled trial design, with randomization and blinding executed as follows. The study adopts a stratified block randomization method, with different age groups (3-17 years old, 18-64 years old, and 65 years old and above) as stratification factors. Subjects will be randomly assigned to different trial groups at a 1:1 ratio through the Interactive Web Response System (IWRS). The randomization code will be generated and kept by the statistician responsible for randomization.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

此项研究将在盲态下进行。每个受试者接受EM和EC/TB-PPD，对受试者、部分研究者及其他参与此项研究的工作人员保持盲态。编盲人员不得参加临床试验工作，同时也不得向参加临床试验工作的任何人员泄露编盲内容。 盲法保持：由于EM与EC/TB-PPD外观不同，将参加研究的团队分成非盲组和盲组。非盲组主要负责试验用药品的管理，并根据研究随机结果对受试者所使用的试验用药品按方案进行配制；另一组为盲组，主要负责将配制好的试验用药品注射液按方案进行注射、进行安全性监测、评估等工作。负责试验用药品制备的药剂师或研究护士不得向受试者、其家属或其他人员泄露任何有关治疗分配的信息，包括研究医生及相关研究人员。

Blinding：

This study will be conducted under blinded conditions. Each subject will receive EM and EC/TB-PPD, and the subjects, some investigators, and other staff involved in this study will be kept blinded. Personnel responsible for blinding are not allowed to participate in the clinical trial work and must not disclose the content of the blinding to any personnel involved in the clinical trial. Maintenance of blinding: Since EM and EC/TB-PPD have different appearances, the research team will be divided into a non-blinded group and a blinded group. The non-blinded group will be mainly responsible for the management of the investigational products and will prepare the investigational products for subjects according to the study randomization results as per the protocol. The other group, the blinded group, will be mainly responsible for injecting the prepared investigational product solution, conducting safety monitoring, and assessment as per the protocol. Pharmacists or research nurses responsible for the preparation of investigational products must not disclose any information regarding treatment allocation to subjects, their families, or other personnel, including study physicians and related researchers.

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

N/A

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

本研究由数据管理员（Data Management，DM）撰写数据管理计划，作为整个数据管理过程的指导性文件，数据管理所有过程均应按照数据管理计划进行操作，数据管理计划应根据项目具体情况进行更新。根据方案要求设计数据采集病例报告表（Case Report Form，CRF），同时形成相应的数据采集填写指南，经申办者审查和批准后实施。 数据管理人员根据研究方案或定稿的MOCK CRF建立数据库（eCRF），由数据管理员进行数据库测试。数据库应对系统登录、数据录入、修改、或删除等数据痕迹进行管理。 本研究将采用电子数据采集系统（Electronic Data Collection，EDC）进行数据的收集和管理。数据管理过程应符合《药物临床试验质量管理规范》（Good Clinical Practice，GCP）及数据管理相应法规要求，遵照数据管理部门的标准操作规程（SOP），确保临床试验数据的真实、准确、完整、可靠和可溯源性（EDC系统将记录所有稽查轨迹）。数据管理的详细内容将在数据管理计划中提供。 EDC系统的访问和权限将依据每个相关人员在研究中的职能而设定。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

This study will have the Data Management Plan written by the Data Manager (DM) to serve as a guiding document for the entire data management process. All data management processes should be conducted in accordance with the Data Management Plan, which should be updated based on the specific circumstances of the project. The Case Report Form (CRF) for data collection will be designed in accordance with the protocol requirements, and a corresponding data collection filling guide will be formed. The CRF will be implemented after being reviewed and approved by the sponsor. The Data Manager will establish the database (eCRF) based on the study protocol or the finalized MOCK CRF, and the database will be tested by the Data Manager. The database should manage the data trails of system login, data entry, modification, or deletion. Electronic Data Collection (EDC) will be used in this study for data collection and management. The data management process should comply with the requirements of the "Good Clinical Practice" (GCP) and relevant data management regulations, and follow the Standard Operating Procedures (SOP) of the data management department to ensure the authenticity, accuracy, completeness, reliability, and traceability of clinical trial data (the EDC system will record all audit trails). The detailed content of data management will be provided in the Data Management Plan. Access to and permissions for the EDC system will be set according to the functions of each relevant person in the study.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-07-30 16:51:20