Status:
UNKNOWN
Immunological Mechanisms of Allergy Immunotherapy
Lead Sponsor:
Rambam Health Care Campus
Conditions:
Allergy Desensitization
Eligibility:
All Genders
18-45 years
Brief Summary
The purpose of the study is to add to the knowledge of mechanisms of immune health. Parameters of the immune system will be followed over time in volunteers allergic to dust mites and bee sting after ...
Detailed Description
The process of immunization as a treatment for allergic disease brings about changes that are not all well understood and the understanding about them is developing constantly. In our study we plan to...
Eligibility Criteria
Inclusion
- Diagnosis of allergic rhinitis and evidence of specific immunoglobulin E antibodies to house dust mite.
- Or A history of a bee sting event that resulted in a systemic allergic reaction with evidence of bee venom-specific immunoglobulin E by skin testing 18-45 years, inclusive at time of initial enrollment General good health and ambulatory at time of enrollment Willing and able to sign Informed Consent Available for follow-up for the planned duration of the study Acceptable medical history by screening evaluation and brief clinical assessment
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Exclusion
- Allergy to multiple allergens Active systemic or serious concurrent illness, including febrile illness on the day of blood withdrawal History of immunodeficiency Known or suspected impairment of immunologic function, including, but not limited to clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, blood pressure \>150/95 at screening, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- Chronic Hepatitis B or C. Recent or current use of immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays are permissible).
- Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
- Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin, Plavix, Aggrenox. May be acceptable after review by investigator.
- Receipt of blood or blood products within the past 6 months Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol History of Guillain-Barré Syndrome
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Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01914029
Start Date
August 1 2013
End Date
July 1 2016
Last Update
August 27 2013
Active Locations (1)
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1
Immunology Clinic Rambam Medical Center
Haifa, Israel, 31096