Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America

Study Overview
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Brief Summary
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This is a research study intending to look at the response of a specific type of allergy cells in the blood (called T cells) to a a type of immunotherapy product known as SPIREs (Synthetic Peptide Immuno-Regulatory Epitopes), across a broad range of subjects. This is a non-interventional study in which no investigational product will be administered to any subject.

Official Title
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Observational, Cross-sectional Analysis of T Cell Responses to Synthetic Peptide Immuno-Regulatory Epitopes (SPIREs) for Multiple Allergens in Subjects With Allergy in North America

Conditions
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Allergy

Intervention / Treatment
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* Other: Blood Sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18-65 years. Willing and able to provide written informed consent. One year history of allergic rhinoconjunctivitis to one or more of cat, short ragweed, Rye grass, or HDM. Positive skin prick test to each allergen for which a subject has a qualifying clinical history. Exclusion Criteria: Clinically relevant history of alcohol or drug abuse. Use of any oral or parenteral (except low dose inhaled) corticosteroids within 2 months prior to the visit or any other immunosuppressive therapy within 3 months prior to the visit. Vaccination/ inoculation within the 6 weeks prior to the first visit. A history of any significant disease or disorder (e.g. autoimmune, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment, severe atopic dermatitis). Subjects who have taken an investigational drug within 6 weeks prior to the visit or are currently participating in any other clinical study. Recent blood donation of an amount of >100 mL. Immunotherapy within the last 5 years to any of the allergens for which a subject would otherwise be eligible on the basis of clinical history and skin prick test result.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blood Sampling<br>Participants allergic to one or more of cat, rye grass, ragweed or house dust mite. | Other: Blood Sampling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of T cell responses to SPIREs |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the distribution of allergen sensitivity across a broad range of common allergens |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ragweed, Rye Grass, Cat, House Dust Mite