Clinical Trial of Mica
Latent Tuberculosis Infection
About this trial
This is an interventional prevention trial for Latent Tuberculosis Infection
Eligibility Criteria
Inclusion Criteria: Age 15 and above (≥15 years old), gender unlimited; 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; Patients with normal body temperature (axillary temperature < 37.3℃); The mean 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: Patients with a history of severe drug allergy, vaccine allergy, allergic constitution or known allergy to experimental drugs; Patients currently suffering from tuberculosis; 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.; Patients with extreme weakness and severe anemia; Patients with a history of convulsions, epilepsy, encephalopathy, and neurological symptoms or signs upon examination; Chest imaging examination showed active tuberculosis; Patients with abnormal thyroid palpation or a history of thyroid/parathyroid disease; 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 before enrollment; Women who are pregnant or breastfeeding, who test positive for pregnancy, or who cannot guarantee contraception during the study period of this clinical trial; Any circumstances which the investigator considers likely to influence the evaluation of the test.
Sites / Locations
- Liujiang district Prevention and Control centerRecruiting
- Liuzhou Center for Disease Control and PreventionRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Treatment Group
Blank Group
Mycobacterium vaccae for injection (Mica) : Dosage form: injection. Main ingredients and contents:Mycobacterium protein 22.50μg/ bottle. Open the aluminum-plastic combination cap of the Xilin bottle, dilute it with 1.0ml sterilized water for injection, shake well, extract the liquid, and inject it deep into the buttocks muscle. Six times every two weeks.
Non-injection drug.