Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein

Summary

Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients. Cohort I was injected with EC and TB-PPD in both arms, and cohort II was injected with EC only

Timeline

Start

2023-04-17

Primary completion

2024-05-13

Completion

2024-05-13

Publications

• Chen J, Zhao L, Zhou X, Mo Y, Kong L, Ma F, Wu L, Huang D, Yang H, Gong L. Safety and Diagnostic Performance of Recombinant Fusion Protein ESAT6-CPF10 Skin Test in A Large Population: A Phase 4 Clinical Trial. J Infect Dis. 2025 Oct 15;232(4):882-891. doi: 10.1093/infdis/jiaf332.

Drugs

Indications