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Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein

Primary Purpose

Latent Tuberculosis Infection

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Recombinant Mycobacterium tuberculosis fusion protein for injection
TB-PPD was injected
Sponsored by
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Latent Tuberculosis Infection

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Guangxi Zhuang Autonomous Region Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
Number of cases in which all adverse events occurred.
Number of cases in which all adverse events occurred within 72 hours after skin testing.
Incidence of SAE
Incidence of SAE within 72 hours after injection

Secondary Outcome Measures

Full Information

First Posted
February 9, 2023
Last Updated
June 7, 2023
Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05746611
Brief Title
Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein
Official Title
To Conduct a Phase IV Clinical Trial of Recombinant Mycobacterium Tuberculosis Fusion Protein in Community Population Aged 6 Months and Above.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Recombinant Mycobacterium tuberculosis fusion protein for injection
Intervention Description
For the suction test, EC0.1ml was injected into the palmar skin of the forearm by the Mondu's method
Intervention Type
Biological
Intervention Name(s)
TB-PPD was injected
Intervention Description
For the aspiration test, 0.1ml TB-PPD was injected into the palmar skin of the forearm by the Mondu's method
Primary Outcome Measure Information:
Title
In Cohort 1, the diameter of redness or induration at the reaction site
Description
In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 0 minute after skin testing.
Time Frame
The skin test was performed at 0 minute after injection.
Title
In Cohort 1, the diameter of redness or induration at the reaction site
Description
In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 24 hours after skin testing.
Time Frame
The skin test was performed at 24 hours after injection.
Title
In Cohort 1, the diameter of redness or induration at the reaction site
Description
In cohort 1, the diameter of redness or induration at the reaction site was measured with a scale at 48 hours after skin testing.
Time Frame
The skin test was performed at 48 hours after injection.
Title
In Cohort 1, the diameter of redness or induration at the reaction site
Description
In cohort 1, the diameter of redness or induration at the reaction site was measured using a scale at 72 hours after skin testing.
Time Frame
The skin test was performed at 72 hours after injection.
Title
In Cohort 2, the diameter of redness or induration at the reaction site
Description
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.
Time Frame
0 minute after the skin test
Title
In Cohort 2, the diameter of redness or induration at the reaction site
Description
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.
Time Frame
Within 48 to 72 hours after skin testing
Title
Number of cases in which all adverse events occurred.
Description
Number of cases in which all adverse events occurred within 72 hours after skin testing.
Time Frame
The skin test was performed 72 hours after injection.
Title
Incidence of SAE
Description
Incidence of SAE within 72 hours after injection
Time Frame
Incidence of SAE within 72 hours after full vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Mo, Master
Phone
13788686968
Email
moyi0415@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Mo, Master
Organizational Affiliation
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Mo, Master
Phone
13788686968
Email
moyi0415@qq.com

12. IPD Sharing Statement

Learn more about this trial

Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein

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