tubercle bacillus
Conditions
Interventions
Experiment group:Intradermal injection with 0.1ml skin test allergen by an 1ml syringe, the injection site is before the 1/3 of left/right regio antebrachii volaris (Piercing intradermal with needle b
Sponsors
Respiratory TB branch of Shanghai public health clinical center
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 40 years old, age difference is not more than 10 years old within the same batch of healthy volunteers, the male to female ratio of cases is 1:1. Body mass index should be in the range of 20 to 27 Body Mass Index BMI: weight (Kg)/ height (M2); 2. Agreed to participate in the test and sign the informed consent; 3. Subjects should comply with the requirements of the clinical trial protocol and be followed; 4. Subjects have no history of specific diagnosis of TB or family history of tuberculosis; 5. Subjects have no tuberculosis inside or outside the lungs, respiratory symptom or systemic symptoms; 6. Subjects have no tuberculosis focus after examination by X-ray chest radiograph and sputum bacilli; 7. Subjects have no acute or chronic disease, acute infectious diseases, dermatoses or skin allergy caused by various reasons; 8. Physical condition: have no history of heart, liver, kidney, gastrointestinal tract, nervous system, or metabolic disturbance, etc. ECG, blood pressure, heart rate, respiratory status and lab test indexes including blood, urine, liver and kidney function, etc are all normal; 9. No close contacts of tuberculosis; 10. Subjects have not participated in other clinical drug trials or inoculated against other prophylactic and immune globulin in the nearly 3 months; 11. Temperature is normal; 12. Stop smoking, drinking and drink contains caffeine.
Exclusion criteria
Exclusion criteria: 1. Health people have close contacts of TB patients, especially excreter in 3 weeks before selection; 2. Suffering from any other serious disease, e.g. cancer,autoimmtme disease, progressive atherosclerosis, diabetes accompanied with complications, chronic obstructive pulmonary disease (COPD) needing oxygen therapy, acute or progressive liver or kidney disease, congestive heart failure, etc.; 3. Subjects have history of allergy, convulsions, epilepsy, cerebropathy, neurological symptoms and signs; 4. Subjects who have impaired or abnormal immune function, e.g. patients treated with immunosuppressor or immunopotentiator, received immunoglobulin preparation or blood products or plasma extraction outside the gastrointestinal tract in 3 months, human immunodeficiency virus or related diseases; 5. Acute febrile illness and infection; 6. Taking part in other clinic trials; 7. Subjects have participated in any other clinical drug trials in 3 months before clinical tests; 8. Allergic constitution, e.g. patients have allergic history to two or more kinds of drugs or food, or drug components; 9. Substance abuse and intemperant; 10. Pregnant or breast feeding women; 11. Mental or physical disability; 12. Informed leavers; 13. Any other cases that may influence the test evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital Signs (HR, BP, T); | — |
Secondary
| Measure | Time frame |
|---|---|
| skin tests (blushes and calluses ) diameter of injection sites, local response ( rash, pain, itching, and skin and mucous membranes ) and a variety of adverse events; | — |
Contacts
Public ContactShuihua Lu
Respiratory TB branch of Shanghai public health clinical center
Outcome results
None listed