Tuberculosis
Conditions
Interventions
control group:One vial of placebo diluted with 1.0ml sterile water for injection, take deep coxal muscle injection after shaking well, once every 2 weeks, 6 times totally.
Experiment group:One vial of Vaccae diluted with 1.0ml sterile water for injection, take deep coxal muscle injection after shaking well, once every 2 weeks, 6 times totally.
Sponsors
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
15 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 15 to 65 years old, all genders; 2. Skin test of tuberculin pure protein derivative (TB-PPD) is strongly positive ( the average diameter of PPD skin test induration is equal or longer than 15mm,and(or)local blisters, necrosis); 3. Agreed to participate in the test and sign the informed consent; 4. Subjects agreed to participate in the experiments and voluntarily signed the informed consent. (guardians of 15-17- year-old subjects should agree, meanwhile); 5. The subjects should comply with the requirements of the clinical trial protocol and be Followed; 6. Have not participated in any other clinical drug trial for nearly three months; 7. Women of childbearing age from 15 to 49 years should agree whit urine pregnancy tests and take effective birth control measures in two years after the medication; 8. Axillary temperature is normal.
Exclusion criteria
Exclusion criteria: 1. Suffering from any other serious disease, e.g. during cancer treatment, 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.; 2. Known allergy to experiment drugs; 3. People with history of specific diagnosis of TB, extrapulmonary tuberculosis or have been cured; 4. People have history of allergy, convulsions, epilepsy, cerebropathy, neurological symptoms and signs; 5. Patients 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; 6. Oral corticosteroids; 7. Patients who have been using oral corticosteroids for more than 1 week, or hormone medication in vitro for a long time; 8. Acute febrile illness and infection; 9. Pregnant or lactating women, or women who have birth plan in flowing 2 years; 10. Any other cases that may influence the test evaluation; 11. Subjects whose compliance is poor, and can not take medicine on time or according to the amount; 12. Patients who are using medicine and food that can influence the result; 13. Pregnant subjects during the test; 14. Patients who are reluctant to continue and require exit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of tuberculosis (TB); | — |
Secondary
| Measure | Time frame |
|---|---|
| lesion degree (Bacteriology indicators, cavity) of patients;the relation between skin test results and paroxysm of TB-PPD;Systemic and local reactions and adverse event; | — |
Countries
China
Contacts
Public ContactZhaojun Mo
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Outcome results
None listed