A Phase 4 interventional study of Mycobacterium Vaccae for Injection in Latent Tuberculosis Infection, sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.. Active, not recruiting at 2 sites in China. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (part of Chongqing Zhifei Biological Products Co., Ltd.) · Phase 4, Interventional, and Prevention
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.
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.
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.
203 studies on the registry are indexed under Latent Tuberculosis; 46 are open to participants now.
This study's planned enrollment of 6,800 is above the median of 311 across 118 interventional studies indexed under Latent Tuberculosis.
Browse Latent Tuberculosis studies →Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. is the lead sponsor of 48 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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
Non-injection drug.
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.
End point of efficacy
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
End point of safety
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
End point of safety
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
End point of immunogenicity
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.
End point of immunogenicity
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.
End point of immunogenicity
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.
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.
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.
This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. →