Status:
SUSPENDED
A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)
Lead Sponsor:
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Conditions:
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The safety, tolerability and immunogenicity of lyophilized recombinant tuberculosis vaccine (AEC/BC02) were studied in a randomized, blind, controlled phase ⅱ A clinical study in patients 18 years and...
Eligibility Criteria
Inclusion
- The age is 18 years old and above, and the gender is not limited;
- I agree to participate in this study and sign the informed consent;
- I can complete the whole process of clinical research in accordance with the requirements of the clinical research program;
- 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;
- 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;
- 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;
- Laboratory tests including blood routine, urine routine, blood biochemistry and other tests are all normal or have no clinical significance;
- There is no abnormality in the electrocardiogram examination or the abnormality has no clinical significance;
- Those who have no history of tuberculosis after medical history inquiry.
Exclusion
- Those who are currently diagnosed with tuberculosis or have a history of tuberculosis and/or tuberculosis treatment;
- There are serious chronic diseases or the disease is in the advanced stage and cannot be controlled smoothly, such as diabetes and thyroid disease;
- 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.;
- 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;
- Existing mental/neurological diseases or history of mental/neurological diseases: those with convulsions, epilepsy, encephalopathy, or family history of mental illness;
- Those who currently suffer from biliary obstruction;
- 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;
- Patients with severe liver insufficiency, or patients with drug-induced hepatitis and acute liver disease caused by any cause;
- Difficulty swallowing, active or clinically significant digestive system diseases, and affecting drug absorption;
- Current patients with active viral hepatitis and/or HIV antibody positive for human immunodeficiency virus and/or current or past syphilis;
- 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;
- 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;
- Those who have participated in any other clinical research and used the investigational drug within 3 months before this clinical research;
- Any other situation that the researcher believes may affect the evaluation of the research.
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05284812
Start Date
February 10 2022
End Date
December 31 2024
Last Update
November 28 2023
Active Locations (1)
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1
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China, 410005