Clinical Trial of Mica

NCT05680415 | Active Not Recruiting Phase 4

• 1 other identifier: LKM-2022-BWK01
• Study Type: interventional
• Target: 6,800
• Locations: 1 country
• Sites: 2

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.

Conditions

Latent Tuberculosis Infection

Outcome Measures

Primary Outcomes (1)

• End point of efficacy

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

  through study completion, an average of 2 year

Secondary Outcomes (6)

• End point of safety

  30 minutes and 30 days after each dose

• End point of safety

  6 months after the first dose to the full dose

• End point of immunogenicity

  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.

• End point of immunogenicity

  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.

• End point of immunogenicity

  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.

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Biological: Mycobacterium Vaccae for Injection

Blank Group

NO INTERVENTION

Non-injection drug.

Interventions

Mycobacterium Vaccae for Injection BIOLOGICAL

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.

Treatment Group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead

Study Sites (2)

Liujiang district Prevention and Control center

Liuchow, Guangxi, 545000, China

Location

Liuzhou Center for Disease Control and Prevention

Liuchow, Guangxi, 545000, China

Location

MeSH Terms

Conditions

Latent Tuberculosis

Interventions

Injections

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yi Mo, Master

  Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The experimental group and the blank control group were randomly assigned in a ratio of 1:1.

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: January 11, 2023
• Study Start: April 19, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

CN (2)