Tuberculosis
Conditions
Interventions
Three negative population with BCG:Arms with the body have intradermal injection with test drug and control drug
Three negative population with BCG placebo:Arms with the body have intradermal injection with test drug and control drug
Sponsors
Jiangsu Provincial Center for Disease Control and prevention
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Screening populations: 1. Aged 18-65 years old, male or female; 2. Subjects agreed to participate in this study and signed informed consent; 3. Subjects can comply with the requirements of the clinical trials to participate in follow-up programs; 4. Have history of tuberculosis upon inquiry; 5. Health: After informed consent, the interrogation suggests no heart, liver, kidney, gastrointestinal tract, nervous system, and a history of mental disorders; 6. Normal axillary temperature (quiet state <=37.0 degree C); 7. Chest X-ray examination no abnormalities. Three negative population: people meet the above criteria by the HIV test result is negative, and the EC allergens, TB-PPD, specifically garma-IFN (T-spot method) three detection methods Results negative population.
Exclusion criteria
Exclusion criteria: Screening populations: 1. Have following serious disease such as advanced tumors,chronic obstructive pulmonary disease with acute exacerbation,acute or progressive liver disease or kidney disease,congestive heart failure etc; 2. Epilepsy and mental illness; 3. Have known or suspected (or might occur from high risk) or abnormal immune or immune dysfunction, including to accept corticosteroids, immunosuppressants or immunostimulants treatment or to accept the protein preparations other than the gastrointestinal tract or blood products or blood components within three months; 4. Acute febrile diseases and infectious diseases; 5. Subjects are participating in other clinical trials;Subjects have participated in any other clinical trials within three months before; 6. Clear history of drug allergy; 7. Pregnant or lactating women; 8. Have a clear history of hypertension and systolic blood pressure =180mmHg and / or diastolic blood pressure >=100mmHg after medications; 9. Researchers think there are any other circumstances that may affect the assessment. Three negative population: 1. Comply with the exclusion criteria for screening population; 2. Having a BCG vaccination Contraindications: Known hypersensitivity to any component of the vaccine; acute illness, serious chronic diseases, acute exacerbation of chronic diseases; immune deficiency, immune dysfunction or are receiving immunosuppressive therapy;encephalopathy, uncontrolled epilepsy and other progressive neurological diseases; eczema or other skin diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observed negative compliance rate of EC allergens for the population after BCG vaccination to evaluate its specificity.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate security of EC allergens in screening populations, BCG vaccinated population after the skin test.;Evaluate relevance of EC allergens, TB-PPD, specifically ?-IFN (T-spot method) three detection methods for screening population and BCG vaccination population; | — |
Countries
China
Contacts
Public ContactLifeng Tao
Outcome results
None listed