Clinical trial NCT01914029: Immunological Mechanisms of Allergy Immunotherapy
Official title: Immunological Mechanisms of Allergy Immunotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergy Desensitization
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 volunteers will be enrolled in each group. The study will include seven treatment groups and one control, total number of participants is 80

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 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.

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 check a large number of immunological parameters to broaden the scope of knowledge of evaluating individuals for immune health across multiple sub fields of medicine and for advancing a basic understanding of immune cell signaling.

The study will involve 70 participants between ages 18-45 of both sexes. Persons enrolled to the study will have been diagnosed with allergic rhinitis caused by dust mite or persons who developed a systemic reaction following bee sting who are candidates to be treated by immunization.

After verification of diagnosis of allergic condition and decision to start immunizations, blood samples will be drawn from participants before immunization weekly for 24 weeks. Blood samples will be analyzed in order to identify immune cell subset differences that change in response to allergy immunotherapy. Comparisons will be made of baseline and stimulation-induced status of protein phosphorylation individuals over the time-series course in which they receive allergy immunotherapy to pinpoint molecular mechanisms underlying desensitization. Evaluations will be made of 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.

Eligibility criteria: 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

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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

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Primary outcomes:
measure: Immunological changes within allergic desensitization treatment
timeFrame: 1. Immunological changes from baseline to 4 months
Secondary outcomes:
measure: Allergen Immunotherapy
timeFrame: participants will be followed weekly for 4 months and once a month afterwards for a year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Immunology Clinic Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Eduardo Shahar, Dr.
role: PRINCIPAL_INVESTIGATOR
References: