Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65(III-healthy)
Phase 3
Completed
- Conditions
- Tuberculosis
- Interventions
- Biological: Bacillus Calmette - GuerinBiological: placebo of Bacillus Calmette - Guerin
- First Posted Date
- 2016-06-10
- Last Posted Date
- 2020-10-01
- Lead Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Target Recruit Count
- 1802
- Registration Number
- NCT02795260
Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen
Phase 3
Completed
- Conditions
- Tuberculosis
- Interventions
- Biological: ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right armBiological: ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm
- First Posted Date
- 2015-12-07
- Last Posted Date
- 2018-04-12
- Lead Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Target Recruit Count
- 1090
- Registration Number
- NCT02623556
- Locations
- 🇨🇳
Wuxi NO.5 People's Hospital, Wuxi, Jiangsu, China
🇨🇳Shanghai Public Health clinical Center, Shanghai, Shanghai, China
Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65
Phase 2
Completed
- Conditions
- Tuberculosis
- Interventions
- Biological: 10μg/ml ESAT6-CFP10Biological: 5μg/ml ESAT6-CFP10Biological: placeboBiological: BCG
- First Posted Date
- 2015-03-17
- Last Posted Date
- 2017-03-17
- Lead Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Target Recruit Count
- 1044
- Registration Number
- NCT02389322
- Locations
- 🇨🇳
Jurong Province Centers for Disease Control and Prevention, Jurong, Jiangsu, China
Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Phase 2
Completed
- Conditions
- Tuberculosis
- Interventions
- Biological: 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right armBiological: 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left armBiological: 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right armBiological: 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm
- First Posted Date
- 2015-01-13
- Last Posted Date
- 2017-03-23
- Lead Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Target Recruit Count
- 192
- Registration Number
- NCT02336542
Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Phase 2
Completed
- Conditions
- Tuberculosis
- Interventions
- Biological: 1μg/ml ESAT6-CFP10 and placeboBiological: 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivativeBiological: 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivativeBiological: 5μg/ml ESAT6-CFP10 and placeboBiological: 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivativeBiological: 10μg/ml ESAT6-CFP10 and placeboBiological: 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivativeBiological: 20μg/ml ESAT6-CFP10 and placebo
- First Posted Date
- 2015-01-01
- Last Posted Date
- 2015-04-09
- Lead Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Target Recruit Count
- 144
- Registration Number
- NCT02329730
Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: ESAT6-CFP10
- First Posted Date
- 2013-12-03
- Last Posted Date
- 2015-03-31
- Lead Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Target Recruit Count
- 32
- Registration Number
- NCT01999231
Phase III Clinical Study of Efficacy and Safety of Vaccae™ to Prevent Tuberculosis
- First Posted Date
- 2013-11-08
- Last Posted Date
- 2018-06-01
- Lead Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Target Recruit Count
- 10000
- Registration Number
- NCT01979900
- Locations
- 🇨🇳
Jin Chengjiang Center for Diseases Control and Prevention, Hechi, Guangxi, Hechi, Guangxi, China
🇨🇳Liuzhou Center for Diseases Control and Prevention, Liuzhou, Guangxi, Liuzhou, Guangxi, China
🇨🇳Liucheng County Diseases Control and Prevention, Liuzhou, Guangxi, Liuzhou, Guangxi, China
© Copyright 2025. All Rights Reserved by MedPath