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Clinical Trial of Mica

Primary Purpose

Latent Tuberculosis Infection

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Mycobacterium Vaccae for Injection
Sponsored by
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Latent Tuberculosis Infection

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 15 and above (≥15 years old), gender unlimited; I (and my guardian) agree to participate in this study and sign the informed consent, willing and able to comply with the requirements of the clinical study protocol; Patients with normal body temperature (axillary temperature < 37.3℃); The mean diameter of the skin test of recombinant mycobacterium tuberculosis fusion protein (EC) is not less than 5mm, or there are blisters, necrosis, lymphangiitis. Exclusion Criteria: Patients with a history of severe drug allergy, vaccine allergy, allergic constitution or known allergy to experimental drugs; Patients currently suffering from tuberculosis; Acute fever diseases, infectious diseases (including but not limited to measles, whooping cough, influenza, pneumonia, etc.), diabetes mellitus with complications, acute or progressive liver or kidney disease, acute conjunctivitis of the eye, acute otitis media, severe heart disease, severe hypertension, myocardial damage, significant vascular sclerosis, patients with endocarditis, patients with malignant tumors, etc.; Patients with extreme weakness and severe anemia; Patients with a history of convulsions, epilepsy, encephalopathy, and neurological symptoms or signs upon examination; Chest imaging examination showed active tuberculosis; Patients with abnormal thyroid palpation or a history of thyroid/parathyroid disease; The interval between other subunit vaccines and inactivated vaccines was less than 7 days, and the interval between attenuated live vaccines was less than 14 days before enrollment; Women who are pregnant or breastfeeding, who test positive for pregnancy, or who cannot guarantee contraception during the study period of this clinical trial; Any circumstances which the investigator considers likely to influence the evaluation of the test.

Sites / Locations

  • Liujiang district Prevention and Control centerRecruiting
  • Liuzhou Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Blank Group

Arm Description

Mycobacterium vaccae for injection (Mica) : Dosage form: injection. Main ingredients and contents:Mycobacterium protein 22.50μg/ bottle. Open the aluminum-plastic combination cap of the Xilin bottle, dilute it with 1.0ml sterilized water for injection, shake well, extract the liquid, and inject it deep into the buttocks muscle. Six times every two weeks.

Non-injection drug.

Outcomes

Primary Outcome Measures

End point of efficacy
Subjects were monitored for confirmed TB cases from enrollment to 24 months after the completion of the injection.

Secondary Outcome Measures

End point of safety
The number of cases of all adverse events occurring within 30 minutes and 30 days after each dose.
End point of safety
Incidence of SAE and AESI within 6 months after the first dose to the full dose
End point of immunogenicity
Humoral Immunity:Changes in the amount of total IgG antibody and IgG subclasses (IgG1 and IgG2).
End point of immunogenicity
Cellular immunity: PBMCs antigen-specific IFN-γ level changes;
End point of immunogenicity
Cellular immunity: Antigen-specific T cells: the ratio of CD4+ T cells, CD8+ T cells and CD3+ T cells changed;
End point of immunogenicity
Cellular immunity: Changes in the absolute number of total white blood cells and specific T cells per unit volume of blood.

Full Information

First Posted
November 27, 2022
Last Updated
June 7, 2023
Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05680415
Brief Title
Clinical Trial of Mica
Official Title
Phase IV Clinical Trial of the Safety, Efficacy, and Immunogenicity of Mycobacterium Vaccae for Injection (Mica) in People Over 15 Years of Age With Latent Mycobacterium Tuberculosis Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Actual)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
August 31, 2027 (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
This study used a randomized, open, blank control design. A total of 6800 patients over 15 years old with latent mycobacterium tuberculosis infection who met the inclusion criteria but did not meet the exclusion criteria were randomly assigned to the experimental group and the blank control group in a 1:1 ratio, with 3400 patients in each group. The experimental group was alternately injected with 1 dose of microcard every two weeks (0-2-4-6-8-10 weeks) in the left and right hip muscle deep, with a total of 6 doses. The blank control group was not injected with drugs.
Detailed Description
Effectiveness evaluation Chest imaging examinations were performed at 6, 12, 18 and 24 months after full injection. The blank control group underwent chest imaging examination at 6, 12, 18 and 24 months after 10 weeks. The confirmed and clinically diagnosed cases of tuberculosis in the experimental group were collected from the first dose to 24 months after full injection and the blank control group from 24 months +10 weeks after enrollment. Follow-up is completed if 8 confirmed cases have been collected after 24 months. If no cases are collected within 24 months, follow-up is required until 8 confirmed cases are collected, and follow-up after 24 months only requires chest imaging every 6 months. Safety evaluation In the experimental group, AE was collected 30 minutes after each dose, AE was collected from the first dose to 30 days after the full dose, and SAE and AESI (including immune system related diseases such as thyroid/parathyroid disease) from the first dose to 6 months after the full dose. All pregnancy events from the first dose to 30 days after the full dose were collected. In the control group, only all AESI (including immune system related diseases such as thyroid/parathyroid diseases) were collected up to 10 weeks and 6 months of enrollment. The test group underwent thyroid palpation examination before injection and 6 months after injection. The blank control group underwent thyroid palpation examination on the day of enrollment, 10 weeks and 6 months after enrollment. Cervical ultrasound examination and five tests of thyroid function were added if there were abnormal thyroid palpation in the experimental group at 6 months after full injection and the blank control group at 10 weeks +6 months. Immunogenicity evaluation Blood samples of the first 100 subjects in the experimental group and the control group were collected for immunogenicity evaluation, which included cellular immunity and humoral immunity. The first 25 subjects in each group were tested for the absolute number of total white blood cells and specific T cells per unit volume of blood. Blood collection time points: 1 month and 12 months before the first dose of the experimental group was injected; The blank control group was the day of enrollment, 1 month +10 weeks and 12 months +10 weeks after enrollment.

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
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The experimental group and the blank control group were randomly assigned in a ratio of 1:1.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Mycobacterium vaccae for injection (Mica) : Dosage form: injection. Main ingredients and contents:Mycobacterium protein 22.50μg/ bottle. Open the aluminum-plastic combination cap of the Xilin bottle, dilute it with 1.0ml sterilized water for injection, shake well, extract the liquid, and inject it deep into the buttocks muscle. Six times every two weeks.
Arm Title
Blank Group
Arm Type
No Intervention
Arm Description
Non-injection drug.
Intervention Type
Biological
Intervention Name(s)
Mycobacterium Vaccae for Injection
Intervention Description
The experimental group was alternately injected with 1 dose of microcard every two weeks (0-2-4-6-8-10 weeks) in the left and right hip muscle deep, and a total of 6 doses were injected.
Primary Outcome Measure Information:
Title
End point of efficacy
Description
Subjects were monitored for confirmed TB cases from enrollment to 24 months after the completion of the injection.
Time Frame
through study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
End point of safety
Description
The number of cases of all adverse events occurring within 30 minutes and 30 days after each dose.
Time Frame
30 minutes and 30 days after each dose
Title
End point of safety
Description
Incidence of SAE and AESI within 6 months after the first dose to the full dose
Time Frame
6 months after the first dose to the full dose
Title
End point of immunogenicity
Description
Humoral Immunity:Changes in the amount of total IgG antibody and IgG subclasses (IgG1 and IgG2).
Time Frame
Treatment group: 1 month and 12 months before drug injection, after full injection; Blank control group: the day after enrollment, 1 month +10 weeks after enrollment, 12 months +10 weeks.
Title
End point of immunogenicity
Description
Cellular immunity: PBMCs antigen-specific IFN-γ level changes;
Time Frame
Treatment group: 1 month and 12 months before drug injection, after full injection; Blank control group: the day after enrollment, 1 month +10 weeks after enrollment, 12 months +10 weeks.
Title
End point of immunogenicity
Description
Cellular immunity: Antigen-specific T cells: the ratio of CD4+ T cells, CD8+ T cells and CD3+ T cells changed;
Time Frame
Treatment group: 1 month and 12 months before drug injection, after full injection; Blank control group: the day after enrollment, 1 month +10 weeks after enrollment, 12 months +10 weeks.
Title
End point of immunogenicity
Description
Cellular immunity: Changes in the absolute number of total white blood cells and specific T cells per unit volume of blood.
Time Frame
Treatment group: 1 month and 12 months before drug injection, after full injection; Blank control group: the day after enrollment, 1 month +10 weeks after enrollment, 12 months +10 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 15 and above (≥15 years old), gender unlimited; I (and my guardian) agree to participate in this study and sign the informed consent, willing and able to comply with the requirements of the clinical study protocol; Patients with normal body temperature (axillary temperature < 37.3℃); The mean diameter of the skin test of recombinant mycobacterium tuberculosis fusion protein (EC) is not less than 5mm, or there are blisters, necrosis, lymphangiitis. Exclusion Criteria: Patients with a history of severe drug allergy, vaccine allergy, allergic constitution or known allergy to experimental drugs; Patients currently suffering from tuberculosis; Acute fever diseases, infectious diseases (including but not limited to measles, whooping cough, influenza, pneumonia, etc.), diabetes mellitus with complications, acute or progressive liver or kidney disease, acute conjunctivitis of the eye, acute otitis media, severe heart disease, severe hypertension, myocardial damage, significant vascular sclerosis, patients with endocarditis, patients with malignant tumors, etc.; Patients with extreme weakness and severe anemia; Patients with a history of convulsions, epilepsy, encephalopathy, and neurological symptoms or signs upon examination; Chest imaging examination showed active tuberculosis; Patients with abnormal thyroid palpation or a history of thyroid/parathyroid disease; The interval between other subunit vaccines and inactivated vaccines was less than 7 days, and the interval between attenuated live vaccines was less than 14 days before enrollment; Women who are pregnant or breastfeeding, who test positive for pregnancy, or who cannot guarantee contraception during the study period of this clinical trial; Any circumstances which the investigator considers likely to influence the evaluation of the test.
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
Liujiang district Prevention and Control center
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuling Qin, master
Phone
19101278236
Email
417407102@qq.com
Facility Name
Liuzhou 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
Baoyang Huang, master
Phone
19978269413
Email
495551851@qq.com

12. IPD Sharing Statement

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Clinical Trial of Mica

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