Latent Tuberculosis InfectionPhase 4NCT05680415
Clinical Trial of Mica
A Phase 4 study testing Mycobacterium Vaccae for Injection in people with Latent Tuberculosis Infection, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis Infection
- What is being tested?
- Mycobacterium Vaccae for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,800 participants
- Where
- 2 sitesChina
- Study dates
- 19 Apr 2023to 31 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Liujiang district Prevention and Control center
Liuzhou, Guangxi, 545000
Liuzhou Center for Disease Control and Prevention
Liuzhou, Guangxi, 545000
About this study
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
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.
Read the 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.
- Conditions
- Latent Tuberculosis Infection
- Being tested
- Mycobacterium Vaccae for Injection
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycobacterium Vaccae for InjectionBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Mycobacterium Vaccae for Injection |
| Blank Group | No intervention | Non-injection drug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
End point of efficacy
Subjects were monitored for confirmed TB cases from enrollment to 24 months after the completion of the injection.
Measured: through study completion, an average of 2 year
Secondary outcomes (6)
End point of safety
The number of cases of all adverse events occurring within 30 minutes and 30 days after each dose.
Measured: 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
Measured: 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).
Measured: 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;
Measured: 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;
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start19 Apr 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent Tuberculosis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group and the blank control group were randomly assigned in a ratio of 1:1.
- Masking
- None (open label)
- Enrolment
- 6,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Mo, Master, Principal investigator, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680415
- Sponsor's protocol ID
- LKM-2022-BWK01
- Status last verified
- Jun 2024
- First submitted
- 27 Nov 2022
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05680415
- Acronym / sponsor ID
- LKM-2022-BWK01
- Conditions
- Latent Tuberculosis Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,800 participants (estimated)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental group and the blank control group were randomly assigned in a ratio of 1:1.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: Mycobacterium Vaccae for InjectionMycobacterium 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. |
| Blank Group | No intervention | –Non-injection drug. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycobacterium Vaccae for InjectionThe 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. | Biological | Treatment Group |
Primary outcome
End point of efficacy
Time frame: through study completion, an average of 2 year
Subjects were monitored for confirmed TB cases from enrollment to 24 months after the completion of the injection.
6 secondary outcomes
End point of safety
Time frame: 30 minutes and 30 days after each dose
End point of safety
Time frame: 6 months after the first dose to the full dose
End point of immunogenicity
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
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Mo, Master principal investigator
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mycobacterium Vaccae for Injection in people with Latent Tuberculosis Infection, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End point of efficacy (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.