Clinical trial
A Multicenter, Randomized, Double-blind, Controlled Phase Ⅲ Trial of Recombinant Mycobacterium Tuberculosis Fusion Protein (EC) for the Diagnosis of Mycobacterium Tuberculosis Infection in 65-year-olds and Above
Name
LKM-2022-EC01
Description
A multicenter, randomized, blind, controlled trial design was used to select 240 tuberculosis (TB) patients, 120 non-tuberculous community population with other lung diseases, and 420 healthy community population without other lung diseases who met the inclusion criteria of this study. Blood supply specific gamma-interferon (T-SPOT) detection was performed first. Then, EC and Purified Protein derivation of tuberculin (TB-PPD) skin tests were performed on both arms, and the recorded results were observed. The first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases were included in the trial subgroup. Physical examination, blood routine, urine routine, liver and kidney function, and electrocardiogram tests were required before and 7 days after skin test after study number assignment.
Trial arms
Trial start
2023-08-03
Estimated PCD
2025-06-30
Trial end
2025-10-31
Status
Recruiting
Phase
Early phase I
Treatment
Recombinant Mycobacterium Tuberculosis Fusion Protein
Dosage form:injection. Main ingredients and contents: Recombinant Mycobacterium tuberculosis fusion protein, 0.3ml, 0.5ml, 1.0ml per bottle.
1. This product is used alone: 0.1ml (5U) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method. 2. This product combined with TB-PPD: 0.1ml(5U) of this product and 0.1ml(5U) of TB-PPD were inhaled respectively, and the product was injected intradermally into the volar side of the left forearm by the Mondu's method. After observing no abnormality for 5 minutes, TB-PPD was injected intradermally into the volar side of the right forearm.
Arms:
Left arm injection EC group, Right arm injection EC group
Other names:
EC
Purified Protein Derivative of Tuberculin
Dosage form:injection. Main ingredients and contents:Pure protein derivatives of tuberculin,0.1ml per bottle.
Usage:0.1ml (5IU) of this product is inhaled and injected into the palmar skin of the forearm by the Mondu's method.
Arms:
Left arm injection EC group, Right arm injection EC group
Other names:
TB-PPD
Size
780
Primary endpoint
Measure the diameter of redness or induration at the reaction site
The skin test was performed at 0 minute after injection.
Measure the diameter of redness or induration at the reaction site
The skin test was performed at 24 hours after injection.
Measure the diameter of redness or induration at the reaction site
The skin test was performed at 48 hours after injection.
Measure the diameter of redness or induration at the reaction site
The skin test was performed at 72 hours after injection.
Evaluate the incidence of all adverse events
Incidence of all adverse events within 7 days after injection.
Evaluate the incidence of serious adverse event (SAE)
Incidence of SAE within 28 days after full vaccination
In subgroup, count the number of patients with changes in clinical significance of blood routine test before skin test compared with that 7 days after skin test
before injection
In subgroup, count the number of patients with changes in clinical significance of urine routine test before skin test compared with that 7 days after skin test
before injection
In subgroup, count the number of patients with changes in clinical significance of liver and kidney function test before skin test compared with that 7 days after skin test
before injection
In subgroup, count the number of patients with changes in clinical significance of electrocardiogram test before skin test compared with that 7 days after skin test
before injection
In subgroup, count the number of patients with changes in clinical significance of blood routine test 7 days after skin test compared with that before skin test
7days after injection
In subgroup, count the number of patients with changes in clinical significance of urine routine test 7 days after skin test compared with that before skin test
7days after injection
In subgroup, count the number of patients with changes in clinical significance of liver and kidney function test 7 days after skin test compared with that before skin test
7days after injection
In subgroup, count the number of patients with changes in clinical significance of electrocardiogram test 7 days after skin test compared with that before skin test
7days after injection
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 780, 'type': 'ESTIMATED'}}
Updated at
2023-08-22
1 organization
Organization
Anhui Zhifei Longcom Biologic Pharmacy