Allergy Desensitization Clinical Trial
Official title:
Immunological Mechanisms of Allergy Immunotherapy
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 receiving immunization therapy. This information will be compared to healthy volunteers without allergy. We aim to bring new understanding of immune processes by this comparison.
| Status | Recruiting |
| Enrollment | 70 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: 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 Exclusion Criteria: 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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Immunology Clinic Rambam Medical Center | Haifa |
| Lead Sponsor | Collaborator |
|---|---|
| Rambam Health Care Campus |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Immunological changes within allergic desensitization treatment | Phenotype changes in time of immune cell subsets count, and relative abundance. Compare the baseline and stimulation-induced status of protein phosphorylation individuals over the time-series course in which they receive allergy immunotherapy and pinpoint molecular mechanisms underlying desensitization. Evaluate cellular mechanisms of allergy immunotherapy by comparing over time and between groups, through serum cytokine profiling and blood gene expression of individuals undergoing allergy immunotherapy shots. |
1. Immunological changes from baseline to 4 months | Yes |
| Secondary | Allergen Immunotherapy | Compare the baseline and stimulation-induced status of protein phosphorylation individuals over the time-series course in which they receive allergy immunotherapy and pinpoint molecular mechanisms underlying desensitization. | participants will be followed weekly for 4 months and once a month afterwards for a year | No |