Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): 5μg/ml ESAT6-CFP10; 10μg/ml ESAT6-CFP10; BCG; placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 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 .; 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 .; 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 .; 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 .
Other intervention name(s): 5μg/mlEC; 10μg/ml EC; Bacillus Calmette-Guerin
Intervention MeSH terms: BCG Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: ESAT6; CFP10; skin test; diagnostic test