Clinical Trial to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old.

Summary

This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety and preliminary efficacy of EEC in the population aged 3 to 75 years old.

In the first stage,180 healthy subjects, 140 tuberculosis（TB）subjects and 40 non-TB subjects with lung diseases aged 18 to 65 years old are divided into different groups through a randomized, blind methods. Every group carry out a low-dose (2.5μg/ml) or high-dose (5μg/ml) study, with 180 subjects in each dose group .Every subject injects intradermally EEC and EC randomly in both arms of the same person. Evaluate the consistency of assay results of EEC, EC and Interferon-Gamma Release Assay（IGRA）.Evaluate the sensitivity, specificity and consistency of assay results of EEC, EC and IGRA in healthy people, TB patients and non-TB patients with lung diseases, and determine the optimal dose of EEC for clinical auxiliary diagnosis of tuberculosis.

In the second stage, 60 healthy subjects and TB subjects aged 3-17 years and 66-75 years old are divided into different groups through a randomized, open, single-arm method with the target dose. Evaluate the safety, tolerance and preliminary efficacy of target dose of EEC in healthy people and TB patients aged 3 to 17 years old and 66 to 75 years old.

Conditions

• Tuberculosis

Interventions

BIOLOGICAL

2.5μg/ml EEC

0.1ml ,one time, containing low dose of 2.5μg/ml of active ingredients

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

Sponsors & Collaborators

• Beijing Chest Hospital, Capital Medical University

  collaborator OTHER

• Wuhan Institute for Tuberculosis Control

  collaborator OTHER

• The Public Health Clinical Center of Chengdu

  collaborator UNKNOWN

• Xuzhou Infectious Disease Hospital

  collaborator UNKNOWN

• Jiangsu Province Centers for Disease Control and Prevention

  collaborator NETWORK

• Changde First People's Hospital

  collaborator UNKNOWN

• Chengdu CoenBiotech Co., Ltd

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-07-18

Primary Completion

2024-05-30

Completion

2024-06-30

Countries

• China

Study Locations