Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Choose healthy subjects and patients with TB, distribute them into different dose groups
      according to the recombinant EC allergen dose from low to high average. Conducting clinical
      trials of TB-PPD or placebo as controlled arms intradermal injection. Do specific interferon
      gamma detection before the skin test，after the test 72h±2h and 144h±2h. Evaluate the safety
      of the recombinant EC allergy , and provide the appropriate dose range for phase IIb clinical
      trials.
    

Detailed description: 
      First, 56 healthy subjects are distributed into different dose groups according to the
      recombinant EC allergen dose from low to high.Conducting clinical trials of TB-PPD as
      controlled arms intradermal injection.Do specific interferon gamma detection before the skin
      test，after the test 72h±2h and 144h±2h. The vital signs (breathing, heart rate, blood
      pressure and temperature), skin reaction at injection site (flush and induration) , local
      reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events; The
      vital signs, blood routine, urine routine, liver and kidney function, electrocardiogram
      （before the skin test,after skin test 144h ）are the main test items,Evaluate the safety of
      the recombinant EC allergy in the expansion of the healthy people , and provide the
      appropriate dose range for phase IIb clinical trials.

      Second，56 patients of TB are distributed different dose groups according to the recombinant
      EC allergen dose from low to high. Conducting clinical trials of TB-PPD as controlled arms
      intradermal injection.Do specific interferon gamma detection before the skin test，after the
      test 72h±2h and 144h±2h. The vital signs (breathing, heart rate, blood pressure and
      temperature),skin reaction at injection site (flush and induration) , local reactions (rash,
      pain, itching and skin mucous membrane) and a variety of adverse events; The vital signs,
      blood routine, urine routine, liver and kidney function, electrocardiogram （before the skin
      test,after skin test 144h ）are the main test items,Evaluate the safety of the recombinant EC
      allergy in patients of TB,and provide the appropriate dose range for phase IIb clinical
      trials.

      Third，32 patients of TB are distributed into different dose groups according to the
      recombinant EC allergen dose from low to high. Conducting clinical trials of placebo as
      controlled arms intradermal injection.Do specific interferon gamma detection before the skin
      test，after the test 72h±2h and 144h±2h. The vital signs (breathing, heart rate, blood
      pressure and temperature), skin reaction at injection site (flush and induration), local
      reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events; The
      vital signs, blood routine, urine routine, liver and kidney function, electrocardiogram
      （before the skin test,after skin test 144h ）are the main test items,Evaluate the safety of
      the recombinant EC allergy in patients of TB on safety.
    

Intervention name(s): 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative; 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative; 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative; 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative; 1μg/ml ESAT6-CFP10 and placebo; 5μg/ml ESAT6-CFP10 and placebo; 10μg/ml ESAT6-CFP10 and placebo; 20μg/ml ESAT6-CFP10 and placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 1μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.; Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 5g/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.; Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 10g/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.; Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 20/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.; Left arm intradermal injection of the placebo of 1μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 1μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.; Left arm intradermal injection of the placebo of 5μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 5μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.; Left arm intradermal injection of the placebo of 10μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 10μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.; Left arm intradermal injection of the placebo of 20μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 20μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.
Other intervention name(s): Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 /TB-PPD; Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10/TB-PPD; Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 /TB-PPD; Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 /TB-PPD; Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10; Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10; Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10; Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: diagnosis of Tuberculosis (TB); ESAT6; CFP10; Phase IIa Clinical Trial