Clinical trial
To Conduct a Phase IV Clinical Trial of Recombinant Mycobacterium Tuberculosis Fusion Protein in Community Population Aged 6 Months and Above.
Name
LKM-2022-EC02
Description
Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients. Cohort I was injected with EC and TB-PPD in both arms, and cohort II was injected with EC only
Trial arms
Trial start
2023-04-17
Estimated PCD
2024-05-31
Trial end
2025-06-30
Status
Recruiting
Phase
Early phase I
Treatment
Recombinant Mycobacterium tuberculosis fusion protein for injection
For the suction test, EC0.1ml was injected into the palmar skin of the forearm by the Mondu's method
Arms:
Cohort 1, Cohort 2
TB-PPD was injected
For the aspiration test, 0.1ml TB-PPD was injected into the palmar skin of the forearm by the Mondu's method
Arms:
Cohort 1
Size
60500
Primary endpoint
In Cohort 1, the diameter of redness or induration at the reaction site
The skin test was performed at 0 minute after injection.
In Cohort 1, the diameter of redness or induration at the reaction site
The skin test was performed at 24 hours after injection.
In Cohort 1, the diameter of redness or induration at the reaction site
The skin test was performed at 48 hours after injection.
In Cohort 1, the diameter of redness or induration at the reaction site
The skin test was performed at 72 hours after injection.
In Cohort 2, the diameter of redness or induration at the reaction site
0 minute after the skin test
In Cohort 2, the diameter of redness or induration at the reaction site
Within 48 to 72 hours after skin testing
Number of cases in which all adverse events occurred.
The skin test was performed 72 hours after injection.
Incidence of SAE
Incidence of SAE within 72 hours after full vaccination
Eligibility criteria
Inclusion Criteria:
* People aged 6 months and above (≥6 months).
* Normal armpit body temperature (body temperature below 37.5℃ from 6 months to 14 years old, body temperature below 37.3℃ from 15 years old and above).
* I or my guardian agree to participate in this study and sign the informed consent, willing and able to comply with the requirements of this clinical study protocol.
Exclusion Criteria:
* Patients with acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute eye conjunctivitis, acute otitis media, extensive skin diseases and allergic diseases
* A pure protein derivative or similar product was used within 3 months prior to the initiation of this trial.
* Participated in other new drug clinical trials within 3 months prior to clinical trials.
* Any circumstances were considered by the investigators to have the potential to influence the assessment of the trial.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60500, 'type': 'ESTIMATED'}}
Updated at
2023-06-08
1 organization
Organization
Anhui Zhifei Longcom Biologic Pharmacy