A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)

This is an interventional prevention trial for Tuberculosis focused on measuring Tuberculosis, Vaccine Read More

Inclusion Criteria:

1. The age is 18 years old and above, and the gender is not limited;
2. I agree to participate in this study and sign the informed consent;
3. I can complete the whole process of clinical research in accordance with the requirements of the clinical research program;
4. Vital signs (reference range of normal values of vital signs: systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg (which can be controlled by taking medicine), pulse 60-100 beats/min, axillary temperature <37.3 ℃ in a quiet state), Physical examination results show no abnormality or abnormality without clinical significance;
5. Negative control population: the test results are EC- and PPD- (the average diameter of EC skin test induration and flush is less than 5mm, and the PPD skin test induration is less than 5mm), and the chest imaging is normal;
6. People with latent infection of Mycobacterium tuberculosis: the test result is EC+ (EC skin test induration or flush ≥5mm), and the chest imaging is normal;
7. Laboratory tests including blood routine, urine routine, blood biochemistry and other tests are all normal or have no clinical significance;
8. There is no abnormality in the electrocardiogram examination or the abnormality has no clinical significance;
9. Those who have no history of tuberculosis after medical history inquiry.

Exclusion Criteria:

1. Those who are currently diagnosed with tuberculosis or have a history of tuberculosis and/or tuberculosis treatment;
2. There are serious chronic diseases or the disease is in the advanced stage and cannot be controlled smoothly, such as diabetes and thyroid disease;
3. Currently suffering from or within 2 years of any of the following serious diseases, such as: advanced tumor, autoimmune disease, progressive atherosclerosis, acute exacerbation of chronic obstructive pulmonary disease, acute or progressive liver or kidney disease, congestive heart failure exhaustion, etc.;
4. Those with known or suspected (or high-risk) immune function impairments or abnormalities, such as those receiving systemic glucocorticoids, immunosuppressants or immunosuppressants within 3 months, and within 3 months Those who received protein preparations or blood products or plasma extracts outside the gastrointestinal tract;
5. Existing mental/neurological diseases or history of mental/neurological diseases: those with convulsions, epilepsy, encephalopathy, or family history of mental illness;
6. Those who currently suffer from biliary obstruction;
7. People with allergic constitution, such as those with a history of allergy to two or more drugs or foods; a history of severe allergy to any component of the test vaccine, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenia Purpura, dyspnea, angioedema, etc.; or a history of the above-mentioned serious side effects after using any vaccine or drug in the past; a history of allergy to isoniazid tablets, rifampicin and rifamycin antibiotics;
8. Patients with severe liver insufficiency, or patients with drug-induced hepatitis and acute liver disease caused by any cause;
9. Difficulty swallowing, active or clinically significant digestive system diseases, and affecting drug absorption;
10. Current patients with active viral hepatitis and/or HIV antibody positive for human immunodeficiency virus and/or current or past syphilis;
11. Women who are pregnant, breastfeeding, or have a positive urine pregnancy test during the screening period, or before vaccination, or who have childbearing plans during the study period;
12. Those who are vaccinated with inactivated vaccine within 14 days before oral administration of chemical drugs, and those who are vaccinated with live attenuated vaccine within 30 days;
13. Those who have participated in any other clinical research and used the investigational drug within 3 months before this clinical research;
14. Any other situation that the researcher believes may affect the evaluation of the research.