Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen

Summary

720 cases TB (Tuberculosis patients) participants、360 cases non-TB participants with lung disease and suspected TB patients who all meet the standard are divided into different groups through a randomized and blind method. Every subject inject intradermally ESAT6-CFP10 and TB-PPD (tuberculin purified protein derivative) in different arms of the same person by blind method. Specific gama-interferon (γ-IFN) detection is needed before the injection.Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we observe all kind of adverse events.

Conditions

• Tuberculosis

Interventions

BIOLOGICAL

ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm

All subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.

BIOLOGICAL

ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm

All subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.

Sponsors & Collaborators

• Shanghai Public Health Clinical Center

  collaborator OTHER_GOV

• Tianjin Haihe Hospital

  collaborator OTHER

• Air Force Military Medical University, China

  collaborator OTHER

• Proswell Medical Corporation

  collaborator INDUSTRY

• Wuhan Institute for Tuberculosis Control

  collaborator OTHER

• Beijing Chest Hospital

  collaborator OTHER

• Wuxi Hospital for Infectious Diseases

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Fuzhou Pulmonary Hospital of Fujian

  collaborator OTHER

• Zhenjiang Third People's Hospital

  collaborator UNKNOWN

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• Shenzhen Third People's Hospital

  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 Institute for Tuberculosis Control

• Naihui Chu, Bachelor · Beijing Chest Hospital

• Qinfang Ou · Wuxi No.5 People's Hospital

• Youlun Li, Doctor · First Affiliated Hospital of Chongqing Medical University

• Xiaohong Chen · Fuzhou Pulmonary Hospital of fujuan

• Hongqiu Pan · Zhenjiang Third People's Hospital

• Xiaodong Mei, Doctor · Anhui Provincial Hospital

• Qunyi Deng, Doctor · Shenzhen Third People's Hospital

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

2015-12-31

Primary Completion

2018-03-31

Completion

2018-03-31

Countries

• China

Study Locations