Phase IV Clinical Trial of the Safety, Efficacy, and Immunogenicity of Mycobacterium Vaccae for Injection (Mica) in People Over 15 Years of Age With Latent Mycobacterium Tuberculosis Infection

LKM-2022-BWK01

This study used a randomized, open, blank control design. A total of 6800 patients over 15 years old with latent mycobacterium tuberculosis infection who met the inclusion criteria but did not meet the exclusion criteria were randomly assigned to the experimental group and the blank control group in a 1:1 ratio, with 3400 patients in each group. The experimental group was alternately injected with 1 dose of microcard every two weeks (0-2-4-6-8-10 weeks) in the left and right hip muscle deep, with a total of 6 doses. The blank control group was not injected with drugs.

2023-04-19

2026-09-30

2027-08-31

Recruiting

Early phase I

6800

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. Patients with normal body temperature (axillary temperature \< 37.3℃); 4. 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: 1. Patients with a history of severe drug allergy, vaccine allergy, allergic constitution or 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 upon examination; 6. Chest imaging examination showed active tuberculosis; 7. Patients with abnormal thyroid palpation or a history of thyroid/parathyroid disease; 8. 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; 9. Women who are pregnant or breastfeeding, who test positive for pregnancy, or who 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 test.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The experimental group and the blank control group were randomly assigned in a ratio of 1:1.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6800, 'type': 'ESTIMATED'}}

2023-06-08