Immunological Mechanisms of Allergy Immunotherapy

NCT ID: NCT01914029

Last Updated: 2013-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-07-31

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.

Conditions

Allergy Desensitization

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo Shahar, Dr.

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Immunology Clinic Rambam Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Eduardo Shahar, Dr.

Role: CONTACT

Phone: 972-4-8543580

Email: ed_shahar@rambam.health.gov.il

Facility Contacts

Eduardo Shahar, Dr.

Role: primary

Other Identifiers

0032-13-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id