NCT07152639

Clinical Trial to Evaluate the Efficacy and Safety of EEC for the Diagnosis of Mycobacterium Tuberculosis Infection in People Aged 3 Years and Above

Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) for the Diagnosis of Mycobacterium Tuberculosis Infection in People Aged 3 Years and Above

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,784 (estimated)
• Sponsor: Chengdu CoenBiotech Co., Ltd · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, blinded, active-controlled clinical trial to evaluate the effectiveness and safety of EEC in the diagnosis of Mycobacterium tuberculosis infection in people aged 3 years and above. Methods: In study 1, the marketed recombinant Mycobacterium tuberculosis fusion protein (EC) was used as a control drug in people aged 3 to 64 years. The sensitivity of EEC in participants with tuberculosis and the specificity in healthy participants and patients with non-tuberculous lung diseases were evaluated compared with recombinant Mycobacterium tuberculosis fusion protein (EC). The clinical positivity criteria of EEC were verified, and the consistency of the two detection methods, as well as the safety of EEC, were evaluated. Study 2: Triple-negative people aged 18 and above (negative in EEC, TB-PPD, and IGRA tests) were screened out from the community population and vaccinated with BCG. EEC and TB-PPD double-arm skin tests were performed 12 weeks after vaccination to evaluate whether there was a significant difference in the negative rate of EEC compared with TB-PPD after BCG vaccination in the triple-negative population. Study 3: A multicenter, positive-controlled, non-inferiority trial design was used for people aged 65 years and above, and the research hypothesis was independently tested to verify the non-inferiority of the sensitivity of this product in tuberculosis patients in this age group compared with IGRA and TB-PPD, as well as the consistency of the diagnostic results of IGRA with non-tuberculous lung diseases and the general community population. At the same time, attention was paid to and analysis of the specificity and safety of EEC in people aged 65 years and above.

Detailed description

This study is a randomized, blinded, active-controlled clinical trial to evaluate the effectiveness and safety of EEC in the diagnosis of Mycobacterium tuberculosis infection in people aged 3 years and above. Study 1: The marketed recombinant tuberculosis fusion protein (EC) was used as a control drug in the population aged 3-64 years: This clinical trial adopted a multicenter, randomized, positive-controlled, blinded, homologous double-arm, non-inferiority trial design in the population aged 3-64 years, aiming to evaluate the sensitivity of EEC compared with recombinant tuberculosis fusion protein (EC) in participants with tuberculosis, the specificity in healthy participants and patients with non-tuberculous lung diseases, verify the clinical positive judgment criteria of EEC, and evaluate the consistency of the two detection methods of EEC and EC and the safety of EEC. Study 2: The marketed tuberculin purified protein derivative (TB-PPD) was used as a control drug in the triple-negative population aged 18 years and above: The triple-negative population (EEC, TB-PPD, and IGRA tests were all negative) was screened out from the community population and vaccinated with BCG. After 12 weeks of vaccination, EEC and TB-PPD were tested in the same arm to evaluate the significant difference in the negative rate of EEC compared with TB-PPD in the triple-negative population after BCG vaccination. Study 3: TB-PPD and in vitro diagnostic reagent IGRA were used as controls for people aged 65 and above: For people aged 65 and above, a multicenter, positive control, non-inferiority trial design was used to conduct a separate study hypothesis to verify the non-inferiority of the sensitivity of this product in tuberculosis patients in this age group compared with IGRA and TB-PPD, as well as the consistency of the diagnostic results of non-tuberculous lung diseases and the general community population with IGRA. At the same time, the specificity and safety of EEC in people aged over 65 were analyzed.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	5μg/ml EEC	0.1ml, one time, containing high dose 5μg/ml of active ingredients
BIOLOGICAL	5 unit（U） EC	0.1 ml , one time, containing 5U of active ingredients
BIOLOGICAL	5 IU TB-PPD	0.1 ml , one time, containing 5IU of active ingredients
DIAGNOSTIC_TEST	IGRA	96-well/plate x 2 plates; 100 tubes/box x 1 box

Timeline

• Start date: 2025-08-09
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2025-09-03
• Last updated: 2025-09-03

Locations

8 sites across 1 country: China