NCT05680415Active, not recruitingPhase 4
Clinical Trial of Mica
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
Source: ClinicalTrials.gov · Last updated 25 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 6800 (estimated)
- First submitted
- 27 Nov 2022
- Start date
- 19 Apr 2023
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Diseases
- Tuberculosis
- NCT number
- NCT05680415
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 6800
- From 19 Apr 2023 to the primary completion date, 30 Sept 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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 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;
Other
- Patients with extreme weakness and severe anemia;
- 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.
Who the study is looking for
- 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.
Age in the registry: 15 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liuzhou center for disease control and prevention Coordinator of this site? Confirm its status | Liuzhou | China | Unknown status |
| Liujiang district Prevention and Control center Coordinator of this site? Confirm its status | Liuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.