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



Status:Recruiting
Conditions:Allergy, Allergy, Neurology
Therapuetic Areas:Neurology, Otolaryngology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:October 2015
End Date:October 2017

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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

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.


Inclusion Criteria:

1. Male or female, aged 18-65 years.

2. Willing and able to provide written informed consent.

3. One year history of allergic rhinoconjunctivitis to one or more of cat, short
ragweed, Rye grass, or HDM.

4. Positive skin prick test to each allergen for which a subject has a qualifying
clinical history.

Exclusion Criteria:

1. Clinically relevant history of alcohol or drug abuse.

2. 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.

3. Vaccination/ inoculation within the 6 weeks prior to the first visit.

4. 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).

5. Subjects who have taken an investigational drug within 6 weeks prior to the visit or
are currently participating in any other clinical study.

6. Recent blood donation of an amount of >100 mL.

7. 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.
We found this trial at
2
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Fairfax, Virginia 22031
Phone: 571-308-1905
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Upland, California 91786
Phone: 909-981-5321
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Upland, CA
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