Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Condition: Healthy
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This clinical study adopts an open, randomized study methods to carry out Recombinant EC
      Allergen on small sample of healthy adults.

      24 healthy adults were included as study objects, they were randomly divided into four groups
      of different Recombinant EC Allergen dose (1, 5, 10μg/mL, maximum tolerated dose 20μg/mL, 6
      person/dose) for single arm intradermal injection, and set up two people as replacement for
      each group (one male and one female).

      Intradermal injection into one third site of healthy subjects' left or right forearm palmaris
      with 0.1ml Recombinant EC Allergen for only one time.

      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 .

      In phaseⅠclinical study, each person can accept only one dose, After injection of the same
      dose of a volunteer group, be sure the next injection of a volunteer at 40 minutes interval.
      Different dose groups: the next dose test should be carried on in the case of no serious
      adverse events appear in 7days after the last one volunteer's injection in a former lower
      dose group.

      Statistical analysis is performed using SAS9.3 software, and all analytic process is
      routinization.
    

Intervention name(s): ESAT6-CFP10
Intervention type(s): Biological
Intervention description(s): 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 .
Other intervention name(s): Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10; EC
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Safety; Tolerability; ESAT6; CFP10; skin test; diagnostic test