drugset / Trial / NCT05680415

Clinical Trial of Mica

NCT05680415 ↗

Phase 4 Active not recruiting 6800 enrolled Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2023-04-19
Primary completion
2026-09-30
Completion
2027-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycobacterium vaccae Unknown 22.5 ug Intramuscular