Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America
This trial is active, not recruiting.
|Sponsor||Adiga Life Sciences, Inc.|
|Start date||October 2015|
|End date||October 2017|
|Trial size||199 participants|
|Trial identifier||NCT02601690, RES-010|
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.
|Observational model||ecologic or community|
Participants allergic to one or more of cat, rye grass, ragweed or house dust mite.
Evaluation of T cell responses to SPIREs
time frame: 2 years
Characterization of the distribution of allergen sensitivity across a broad range of common allergens
time frame: 2 years
Male or female participants from 18 years up to 65 years old.
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.
|Official title||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|
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