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

PHASE2CompletedINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

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.

All Listed Sponsors
collaborator

Shanghai Public Health Clinical Center

OTHER_GOV

collaborator

Tianjin Haihe Hospital

OTHER

collaborator

Wuhan Institute for Tuberculosis Control

OTHER

collaborator

Proswell Medical Corporation

INDUSTRY

collaborator

Air Force Military Medical University, China

OTHER

lead

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

INDUSTRY

NCT02336542 - Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 | Biotech Hunter | Biotech Hunter