Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Condition: Healthy
MeSH terms: Tuberculosis
Intervention: ESAT6-CFP10
Intervention description: 32 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects(three male and three female) , at the same time set up two people for substitute (one male and one female) . ESAT6-CFP10 administered intradermally by the mantoux injection technique. Each receives only one dosage in right or left arm .
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Tolerability; ESAT6; CFP10; skin test; diagnostic test

Summary:

      In the tests, small sample of clinical study about Recombinant Mycobacterium Tuberculosis
      Allergen ESAT6-CFP10 ( Recombination EC Allergen） healthy adults was carried out.

      24 healthy adults were included as study objects, they were randomly divided into four groups
      of different Recombinant Allergen EC dose (1, 5, 10μg/mL, maximum tolerated dose 20μg/mL, 6
      person/dose) for single arm intradermal injection.

      The main examination items :vital signs (breathing, heart rate, blood pressure, body
      temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after
      injection, skin reactivity (redness and/or induration) diameter of injection sites,local
      reaction ( rash, pain, itching, and skin and mucous membranes ) ,a variety of adverse
      events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films
      before and 7 days after intradermal injection .

      Preliminary evaluation of safety and tolerability of Recombinant Allergen EC applied in
      humans, which can provide a safe dosage range for phase II clinical study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged from 18 to 40 years old, age difference is not more than 10 years old within the
             same batch of healthy volunteers, the male to female ratio of cases is 1:1. Body mass
             index should be in the range of 20 to 27 Body Mass Index BMI: weight (Kg)/ height
             (M2);

          -  Agreed to participate in the test and sign the informed consent;

          -  Subjects should comply with the requirements of the clinical trial protocol and be
             followed;

          -  Subjects have no history of TB (Tuberculosis)or family history of tuberculosis;

          -  People have no pulmonary tuberculosis or extrapulmonary tuberculosis,respiratory
             symptom or systemic symptoms;

          -  People have no tuberculosis focus after examination by X-ray chest radiograph and
             sputum bacilli;

          -  Subjects have no acute or chronic disease, acute infectious diseases, dermatoses or
             skin allergy caused by various reasons;

          -  Physical condition: have no history of heart, liver, kidney, gastrointestinal tract,
             nervous system, or metabolic disturbance, etc. ECG, blood pressure, heart rate,
             respiratory status and lab test indexes including blood, urine, liver and kidney
             function, etc are all normal within 4 weeks before screening;

          -  No close contacts of tuberculosis;

          -  Subjects have not participated in other clinical drug trials or inoculated against
             other prophylactic and immune globulin in the nearly 3 months;

          -  Temperature is normal;

          -  Stop smoking, drinking and drinking contains caffeinated.

        Exclusion Criteria:

          -  Health people have close contacts of TB (Tuberculosis)patients, especially excreter in
             3 weeks before selection;

          -  Suffering from any other serious disease, e.g. during cancer treatment, autoimmune
             disease, progressive atherosclerosis, diabetes accompanied with complications, chronic
             obstructive pulmonary disease (COPD) needing oxygen therapy, acute or progressive
             liver or kidney disease, congestive heart failure, etc.;

          -  People have history of allergy, convulsions, epilepsy, cerebropathy, neurological
             symptoms and signs;

          -  Patients who have impaired or abnormal immune function, e.g. patients treated with
             immunosuppressor or immunopotentiator, received immunoglobulin preparation or blood
             products or plasma extraction outside the gastrointestinal tract in 3 months, human
             immunodeficiency virus or related diseases;

          -  Acute febrile illness and infection;

          -  Taking part in other clinic trials;

          -  Subjects have participated in any other clinical drug trials in 3 months before our
             clinical tests;

          -  Allergic constitution, e.g. patients have allergic history to two or more kinds of
             drugs or food, or drug components;

          -  Substance abuse and alcoholics ;

          -  Pregnant or breast feeding women;

          -  Mental or physical disability;

          -  Informed leavers;

          -  Any other cases that may influence the test evaluation.