Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65(III-healthy)
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators recruit about 1800 cases participants who has signed ICF,then do some
      physical examinations for these people, including ecg, X-ray, HIV,blood pressure, specific
      gamma-interferon detection ,collection of medical history and the like .These subjects who
      meet the standard are considered as study population I. Population I are injected
      intradermally with ESAT6-CFP10 and Tuberculin purified protein derivative(TB-PPD) at
      different arm of the same subject and get at least 360 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 ESAT6-CFP10
      and TB-PPD at different arm of the same subject 12 weeks after immunity.
    

Detailed description: 
      The investigators recruit about 1800 cases participants who has signed ICF,then do some
      physical examinations for these people, including ecg, X-ray, HIV,blood pressure, specific
      gamma-interferon detection(γ-IFN) ,collection of medical history and the like .These subjects
      who meet the standard are considered as study population I. Population I are injected
      intradermally with ESAT6-CFP10 and Tuberculin purified protein derivative(TB-PPD) at
      different arm of the same subject and get at least 360 participants whose three kinds of
      detection result are all negative(specific gamma-interferon detection ,TB-PPD and ESAT6-CFP10
      ) and are considered as study population II.Then,they are immune to the Bacillus Calmette
      -Guerin(BCG) vaccine or the placebo of the BCG(BCG and the palcebo ratio of 2:1 ),they are
      incorporated into the Population III. Do specific gamma-interferon detection before the skin
      test,then inject intradermally with ESAT6-CFP10 and TB-PPD at different arm of the same
      subject 12 weeks after immunity. Evaluate the specificity of the ESAT6-CFP10 allergen by
      negative coincidence rate for BCG vaccinated crowd ,and the safety of ESAT6-CFP10 in all
      participant,and the correlation between ESAT6-CFP10 ,TB-PPD and γ-IFN.
    

Intervention name(s): Bacillus Calmette - Guerin; placebo of Bacillus Calmette - Guerin
Intervention type(s): Biological; Biological
Intervention description(s): The participants are injection intradermally with 0.1ml ESAT6-CFP10(EC) in the right OR left arm and TB-PPD in the other arm(right OR left) after 12 weeks immunization of BCG .; The participants are injection intradermally with 0.1ml ESAT6-CFP10(EC) in the right OR left arm and TB-PPD in the other arm(right OR left) after 12 weeks immunization of placebo of BCG .
Other intervention name(s): BCG; placebo of BCG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: ESAT6; CFP10; skin test; diagnostic test