NCT02389322

Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65

Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65,Adopting Randomized Blinded and Parallel Controlled Method

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,044 (actual)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The investigators select 500 subjects who meet the standard and are considered as study population I. Do specific gamma-interferon detection before the skin test， then inject intradermally with two dosage ESAT6-CFP10 and Tuberculin purified protein derivative (TB-PPD) at different arm of the same subject and get 192 participants whose three kinds of detection result are all negative and are considered as study population II.Then,they are immune to the Bacillus Calmette-Guerin (BCG) vaccine or the placebo of the BCG. Do specific gamma-interferon detection before the skin test， then inject intradermally with two dosage ESAT6-CFP10 and TB-PPD at different arm of the same subject 12 weeks after immunity.Negative rate of ESAT6-CFP10 after vaccination BCG as the main index , evaluate the specificity of different doses of ESAT6-CFP10, and conform the optimal dose of ESAT6-CFP10.

Detailed description

1.the correlation of three detection methods for study population I 500 study population I are randomly divided into two different dose group on average, according to ESAT6-CFP10 dose(5μg/ml or 10μg/ml). Do specific gamma-interferon(γ-IFN) detection before the skin test，then inject intradermally with 5μg/ml ESAT6-CFP10 or 10μg/ml ESAT6-CFP10 and TB-PPD at different arm of the same subject.Evaluate respectively the positive rate of three detection methods 、the correlation of three detection methods and the security of study population I after application for ESAT6-CFP10 . 2.screen study population II Choose those participants, whose result of three detection (ESAT6-CFP10、TB-PPD andγ-IFN ) all negative, HIV negative and chest X-ray no abnormalities, into study population II. 3.study population II vaccinate BCG or placebo Study population II ,according to the same proportion ,are randomly divided into four group in double blinded state,: 5μg/ml ESAT6-CFP10 after BCG immunization, 10μg/ml ESAT6-CFP10 after BCG immunization, 5μg/ml ESAT6-CFP10 after placebo-controlled immunization , 10μg/ml ESAT6-CFP10 after placebo-controlled immunization.They vaccinate BCG or the placebo of BCG. 4.Inject ESAT6-CFP10 12 weeks after inoculation in study population II The investigators draw blood and operate specific gamma-interferon(γ-IFN) detection before the skin test，then inject intradermally with 5μg/ml ESAT6-CFP10 or 10μg/ml ESAT6-CFP10 (in double blinded state) and TB-PPD at different arm of the same subject ,according to the above grouping scheme. Calculate the negative coincidence rate and the correlation of three detection methods, and observe the safety of ESAT6-CFP10 in study population II at the same time.Evaluate the specificity of different doses of ESAT6-CFP10, negative rate of ESAT6-CFP10 after vaccination BCG as the main index. And finally conform the optimal dose of ESAT6-CFP10.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	5μg/ml ESAT6-CFP10	The participants are injection intradermally with 0.1 ml 5μg/ml ESAT6-CFP10 12 weeks after BCG immunization or placebo immunization.This biological diagnostic reagents is injection agent .Every subject apply for the 5μg/mlRecombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 only one time after choosing into study population II .
BIOLOGICAL	10μg/ml ESAT6-CFP10	The participants are injection intradermally with 0.1 ml 10μg/ml ESAT6-CFP10 12 weeks after BCG immunization or placebo immunization.This biological diagnostic reagents is injection agent .Every subject apply for the 10μg/mlRecombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 only one time after choosing into study population II .
BIOLOGICAL	BCG	The participants are injected intradermally with 0.1 ml BCG.This BCG is Freeze-dried agent and with five people dose of each bottle,so each bottle of BCG must dissolve by 0.5ml special diluent before administration.Every subject apply for the BCG vaccine only one time after choosing into study population II .
BIOLOGICAL	placebo	The participants are injected intradermally with 0.1 ml placebo of Bacillus Calmette-Guerin.This placebo is Freeze-dried agent and with five people dose of each bottle ,so each bottle must dissolve by 0.5ml special diluent before administration.Every subject apply for the BCG vaccine only one time after choosing into study population II .

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-07-01
• Completion: 2015-09-01
• First posted: 2015-03-17
• Last updated: 2017-03-17

Locations

1 site across 1 country: China