Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

Summary

96 TB subjects and 96 non-TB subjects with lung disease who all meet the standard are divided into different groups through a randomized, blind methods.Every subject inject intradermally ESAT6-CFP10 and TB-PPD in different arms of the same person.Specific γ- IFN(gamma interferon) detection is needed before the injection.Evaluate the sensitivity (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence rate of ESAT6-CFP10 in the tuberculosis patients and non-tuberculosis patients with lung diseases, and determine the optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of tuberculosis.

Conditions

• Tuberculosis

Interventions

BIOLOGICAL

5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm

TB subjects and non-TB subjects with lung disease inject 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same person and different arm.

BIOLOGICAL

5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm

TB subjects and non-TB subjects with lung disease inject 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm.

BIOLOGICAL

10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm

TB subjects and non-TB subjects with lung disease inject 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same person and different arm.

BIOLOGICAL

10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm

TB subjects and non-TB subjects with lung disease inject 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm.

Sponsors & Collaborators

• Shanghai Public Health Clinical Center

  collaborator OTHER_GOV

• Tianjin Haihe Hospital

  collaborator OTHER

• Wuhan Institute for Tuberculosis Control

  collaborator OTHER

• Proswell Medical Corporation

  collaborator INDUSTRY

• Air Force Military Medical University, China

  collaborator OTHER

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Shuihua Lu, Bachelor · Shanghai Public Health Clinical Center

• Qi Wu, Master · Tianjin Haihe Hospital

• Weihua Wang, Doctor · Wuhan Insititute for Tuberculosis Control

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2015-07-31

Completion

2015-07-31