Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above

Launched by ANHUI ZHIFEI LONGCOM BIOLOGIC PHARMACY CO., LTD. · Jun 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for latent tuberculosis infection (LTBI) in people aged 65 and older. The researchers want to see how well a special protein derived from the tuberculosis bacteria works in helping patients with LTBI. They are looking for 240 participants who are confirmed TB patients, 120 people with other lung diseases that are not TB, and 420 healthy individuals without any lung issues. To qualify for the study, participants must be 65 years or older, have a normal body temperature, and meet specific health criteria set by the researchers.

Participants in the trial can expect to undergo some tests, including blood tests and skin tests, to check for TB. They'll also have a physical examination and other routine health checks before and after the skin test. The study is currently recruiting participants, and it's important that those interested can understand the trial's requirements and agree to participate voluntarily. This trial could provide valuable information about new treatment options for TB in older adults.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 65 years old and above (≥ 65 years old), male or female, the subjects themselves voluntarily participate in this study, sign the informed consent form, and can understand and comply with the requirements of the trial protocol to participate in follow-up.
• • Normal underarm body temperature (\< 37.3 °C);
• • Tuberculosis patients: pulmonary tuberculosis patients and extrapulmonary tuberculosis patients diagnosed by researchers as confirmed cases of tuberculosis and clinically diagnosed cases. Refer to the "WS288-2017 Tuberculosis Diagnostic Criteria" to formulate the diagnostic criteria for pulmonary tuberculosis in this protocol, see Annex 1 for details; The diagnostic criteria for extrapulmonary tuberculosis were formulated with reference to the Technical Guidelines for Tuberculosis Prevention and Control in China (2021 edition of the Chinese Center for Disease Control and Prevention), as detailed in Annex 2.
• • Non-tuberculous community population with other lung diseases: there is a clear lung disease, but the study physician can exclude pulmonary tuberculosis based on the patient's clinical manifestations, chest imaging and laboratory tests. Diagnostic criteria for their main types of nontuberculous other lung diseases can be found in Annex 3;
• • Community healthy people without other lung diseases: those who have no history of tuberculosis, no suspicious symptoms of tuberculosis, no history of respiratory tract and recent respiratory symptoms, and no obvious abnormalities in both lungs on chest imaging (DR) examination; After consultation, there is no history of heart, liver, kidney, digestive tract, nervous system, or psychiatric abnormalities.
• Exclusion Criteria:
• • Combined with the following serious diseases, such as advanced tumors, acute exacerbation of chronic obstructive pulmonary disease, acute or progressive liver disease or kidney disease, decompensated stage of congestive heart failure, autoimmune diseases (except those who do not need to use immune agents in the stable period), primary immunodeficiency diseases, etc.;
• • Those suffering from acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute conjunctivitis, acute otitis media, extensive skin diseases and allergies;
• • Those with known or suspected (or high-risk occurrence possibility) immune impairment or abnormalities, such as those receiving immunosuppressants or immune booster therapy, receiving glucocorticoids, immunoglobulin preparations other than the gastrointestinal tract or blood products or plasma extracts within 1 month;
• • Those who have positive human immunodeficiency virus (HIV) antibody test results;
• • Those who are participating in other new drug clinical trials or have participated in any other new drug clinical trials within 3 months before this clinical trial;
• • Fasting blood glucose ≥ 10mmol/L after drug control;
• • Blood pressure range: systolic blood pressure ≥ 180 mmHg and (or) diastolic blood pressure ≥ 110 mmHg (those who take drugs are uncontrollable);
• • Any situation that the investigator believes is poor adherence or may affect the evaluation of the trial.