Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein

Study Overview
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Brief Summary
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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

Detailed Description
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Assessment of effectiveness: In cohort 1, the injection site reaction was examined at 0min, 24h, 48h and 72h after skin test, and the transverse and longitudinal diameters of the erythema and induration were measured and recorded in millimeters (mm), the larger the erythema or induration. Any blisters, necrosis, lymphangitis should be faithfully recorded. In cohort 2, the injection site reaction was examined at 0min and 48-72 h after skin test, and the transverse and longitudinal diameters of the erythema and induration were measured and recorded in millimeters (mm), the larger the erythema or induration. Any blisters, necrosis, lymphangitis should be faithfully recorded. Safety assessments: The safety assessment included all expected and unexpected medical events that occurred during the observation period of the clinical trial (within 72 hours after the skin test) and were related or unrelated to the injection of the investigational drug. These included specific reactions such as redness, induration, blister, necrosis, and lymphangitis at the injection site (palmar forearm). Common and occasional adverse reactions include: Local adverse reactions: injection site pruritus, injection site pain, injection site rash; Systemic adverse reactions included fever, headache, nausea, fatigue, myalgia, diarrhea, vomiting, paresthesia.

Official Title
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To Conduct a Phase IV Clinical Trial of Recombinant Mycobacterium Tuberculosis Fusion Protein in Community Population Aged 6 Months and Above.

Conditions
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Latent Tuberculosis Infection

Intervention / Treatment
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* Biological: Recombinant Mycobacterium tuberculosis fusion protein for injection
* Biological: TB-PPD was injected


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Recombinant Mycobacterium Tuberculosis Fusion Protein (EC): 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. Purified protein derivative (TB-PPD) : Dosage form: Injection. Main components and contents: Purified protein derivative of tuberculin 50IU/ml. 0.1ml (5U) of the product was inhaled and injected into the palmar skin of the forearm by the Mondu's method. | Biological: Recombinant Mycobacterium tuberculosis fusion protein for injection<br>* For the suction test, EC0.1ml was injected into the palmar skin of the forearm by the Mondu's method<br>Biological: TB-PPD was injected<br>* For the aspiration test, 0.1ml TB-PPD was injected into the palmar skin of the forearm by the Mondu's method<br>|
| Experimental: Cohort 2<br>Recombinant Mycobacterium Tuberculosis Fusion Protein (EC): 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. | Biological: Recombinant Mycobacterium tuberculosis fusion protein for injection<br>* For the suction test, EC0.1ml was injected into the palmar skin of the forearm by the Mondu's method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In Cohort 1, the diameter of redness or induration at the reaction site | In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 0 minute after skin testing. | The skin test was performed at 0 minute after injection. | 
| In Cohort 1, the diameter of redness or induration at the reaction site | In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 24 hours after skin testing. | The skin test was performed at 24 hours after injection. | 
| In Cohort 1, the diameter of redness or induration at the reaction site | In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 48 hours after skin testing. | The skin test was performed at 48 hours after injection. | 
| In Cohort 1, the diameter of redness or induration at the reaction site | In cohort 1, the diameter of redness or induration at the reaction site was measured using a scale at 72 hours after skin testing. | The skin test was performed at 72 hours after injection. | 
| In Cohort 2, the diameter of redness or induration at the reaction site | In cohort 2, the diameter of skin redness or induration at the injection site was measured with a scale at 0 minute after the skin test. | 0 minute after the skin test | 
| In Cohort 2, the diameter of redness or induration at the reaction site | In cohort 2, the diameter of skin redness or induration at the primary injection site was measured with a scale between 48 and 72 hours after skin testing. | Within 48 to 72 hours after skin testing | 
| Number of cases in which all adverse events occurred. | Number of cases in which all adverse events occurred within 72 hours after skin testing. | The skin test was performed 72 hours after injection. | 
| Incidence of SAE | Incidence of SAE within 72 hours after injection | Incidence of SAE within 72 hours after full vaccination |