latent tuberculosis infection
Conditions
Interventions
Treatment Group:The experimental group was alternately injected with 1 dose of Mycobacterium Vaccae for Injection every two weeks (0-2-4-6-8-10 weeks) in the left and right hip muscle deep, and a tota
Blank group:Non-injection drug
Sponsors
Institutional Review Board of Guangxi Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 15 and above (=15 years old), gender unlimited; 2. I (and my guardian) agree to participate in this study and sign the informed consent, willing and able to comply with the requirements of the clinical study protocol; 3.the body temperature is normal (axillary temperature < 37.3?); 4. The average diameter of the skin test of recombinant mycobacterium tuberculosis fusion protein (EC) is not less than 5mm, or there are blisters, necrosis, lymphangiitis.
Exclusion criteria
Exclusion criteria: 1. Patients with severe drug allergy, vaccine allergy history, allergic constitution and known allergy to experimental drugs; 2. Patients currently suffering from tuberculosis; 3. Acute fever diseases, infectious diseases (including but not limited to measles, whooping cough, influenza, pneumonia, etc.), diabetes mellitus with complications, acute or progressive liver or kidney disease, acute conjunctivitis of the eye, acute otitis media, severe heart disease, severe hypertension, myocardial damage, significant vascular sclerosis, patients with endocarditis, patients with malignant tumors, etc.; 4. Patients with extreme weakness and severe anemia; 5. Patients with a history of convulsions, epilepsy, encephalopathy and neurological symptoms or signs after examination; 6. Chest imaging examination showed active tuberculosis; 7. Patients with abnormal thyroid palpation or a history of thyroid/parathyroid disease; 8. Before enrollment, the interval between other subunit vaccines and inactivated vaccines was less than 7 days, and the interval between attenuated live vaccines was less than 14 days; 9. Pregnant women, breastfeeding women, pregnancy test positive, or cannot guarantee contraception during the study period of this clinical trial; 10. Any circumstances which the investigator considers likely to influence the evaluation of the trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Antigen-specific total IgG Antibodies and IgG subclasses (IgG1 and IgG2);Changes in antigen-specific IFN-? levels in PBMCs;Antigen-specific T cells: CD4+ T cells, CD8+ T cells; Changes in the proportion of CD3+ T cells;Absolute number of total white blood cells per unit volume of blood;Absolute number of specific T cells per unit volume of blood; | — |
Countries
China
Contacts
Public ContactZhaojun Mo
Guangxi Center for Disease Control and Prevention
Outcome results
None listed