Tuberculosis
Conditions
Interventions
EM/EC Double-arm Clinical Trial Group: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 u
EM/TB-PPD Double-arm Clinical Trial Group:All investigational products are injected intradermally into the volar aspect of the forearm using the Mantoux method. For every subject, the left arm is alwa
Sponsors
Beijing Chest Hospital, Capital Medical University,
Wuhan Pulmonary Hospital (Wuhan Municipal Tuberculosis Prevention and Treatment Institute),
Eligibility
Sex/Gender
All
Age
3 Years to No maximum
Inclusion criteria
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 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
Exclusion criteria
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 th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximum transverse diameters of the erythema at the injection site (unit: mm);The maximum longitudinal diameters of the erythema at the injection site (unit: mm);The maximum transverse diameters of the induration at the injection site (unit: mm);The maximum longitudinal diameters of the induration at the injection site (unit: mm);blister at the injection site;lymphangitis at the injection site;necrosis at the injection site;Whole blood IFN-? release levels in response to Mycobacterium tuberculosis-specific antigens; | — |
Countries
China
Contacts
Public ContactNaihui Chu, Wenjun Nie; Juan Du, Yuehua Li
Beijing Chest Hospital, Capital Medical University; Wuhan Pulmonary Hospital (Wuhan Municipal Tuberculosis Prevention and Treatment Institute)
Outcome results
None listed