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

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.

Conditions

• Tuberculosis

Interventions

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

Sponsors & Collaborators

• Beijing Chest Hospital, Capital Medical University

  collaborator OTHER

• Wuhan Pulmonary Hospital

  collaborator OTHER

• Changsha Central Hospital

  collaborator OTHER

• The First Affiliated Hospital of Xinxiang Medical College

  collaborator OTHER

• LiuZhou People's Hospital

  collaborator OTHER

• Wuhan Central Hospital

  collaborator OTHER

• Yichang Central People's Hospital

  collaborator OTHER

• Chengdu CoenBiotech Co., Ltd

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-08-09

Primary Completion

2026-05-01

Completion

2026-07-01

Countries

• China

Study Locations