Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: 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 description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: diagnosis of Tuberculosis (TB); ESAT6; CFP10; Phase IIa Clinical Trial

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.
    

Eligibility criteria:

        Inclusion Criteria of healthy subjects:

          1. 18 to 65 years old

          2. Consent and signed ICF(informed consent forms)

          3. Comply with follow-up

          4. No history or family history of TB(tuberculosis)

          5. Without the internal and external of pulmonary tuberculosis ; no symptoms of
             respiratory tract and other body parts for TB

          6. The examination such as X-ray chest radiograph, sputum bacteria confirmed
             non-tuberculosis (TB)

          7. No uncontrolled kinds of acute or chronic disease or acute infectious diseases or skin
             disease or skin allergies due to a variety of causes

          8. Physical condition : No obvious heart, liver, kidney, gastrointestinal tract, nervous
             system, mental disorder and metabolic abnormalities and other medical history from
             signed informed consent to the injection within four weeks prior to delivery ;by the
             comprehensive physical examination showed electrocardiogram, blood pressure, heart
             rate, breathing and laboratory tests, including blood, urine routine, liver, kidney
             and other various biochemical test all without exception or slightly unusual but does
             not affect our research

          9. Did not attend any other new drug clinical trials and not vaccinate prevention
             products and immunoglobulin for nearly 3 months

         10. Normal axillary temperature(quiet condition ≤37.0 ℃)

         11. No smoking, no alcohol and drinking caffeinated beverages during the study

        Exclusion Criteria of Healthy volunteers:

          1. Has the following serious disease, such as advanced cancer, diabetes, chronic
             obstructive pulmonary disease (copd) in acute episodes, acute/ progressive liver
             disease or kidney disease, congestive heart failure, etc

          2. Have seizures, epilepsy, brain and nervous system symptoms or signs of history

          3. Has known or suspected (or risk possible) immune damaged or abnormal functional ,
             accept glucocorticoid and immunosuppressants or immunopotentiator treatment, outside
             the gastrointestinal tract protein or blood products or plasma extraction in 3 months,
             immunodeficiency virus infection or related diseases

          4. Has acute febrile diseases and infectious diseases

          5. Participate in other new drug clinical trials

          6. Participated in any other new drug clinical trials in 3 months

          7. Allergic people who have histories of allergy to two or more drugs/food allergy and
             physical scars, are allergic to alcohol or drugs known to the group of points

          8. Women who are in pregnancy or lactation

          9. People with mental or physical disabilities

         10. Researchers consider that any conditions may affect the trial evaluation

        Inclusion Criteria of TB (tuberculosis)subjects:

          1. Diagnosis TB according to the health of the People's Republic of China industry
             standard WS 288-2008 tuberculosis diagnostic criteria

          2. Aged 18 to 65 years old

          3. Consent and signed ICF to participate in this study

          4. Comply with the requirements of the clinical research plan for follow-up

        Exclusion Criteria of TB volunteers:

          1. Have the following serious disease, such as advanced cancer, diabetes, chronic
             obstructive pulmonary disease (copd) in acute episodes, acute/ progressive liver
             disease or kidney disease, congestive heart failure, etc

          2. Have seizures, epilepsy, brain and nervous system symptoms or signs of history;

          3. Have known or suspected (or risk possible) immune damaged or abnormal functional ,
             accept glucocorticoid and immunosuppressants or immunopotentiator treatment, outside
             the gastrointestinal tract protein or blood products or plasma extraction in 3 months,
             immunodeficiency virus infection or related diseases

          4. People in the pyrogenic stage with febrile diseases or infectious diseases (non
             tuberculosis)

          5. Participate in other new drug clinical trials

          6. Participated in any other new drug clinical trials in 3 months;

          7. Allergic people who have histories of allergy to two or more drugs/food allergy and
             physical scars, are allergic to alcohol or drugs known to the group of points;

          8. Women who are in pregnancy or lactation;

          9. People with mental or physical disabilities;

         10. Researchers consider that any conditions may affect the trial evaluation.