Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Alle… (NCT02601690) | Clinical Trial Compass
TerminatedNot Applicable
Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America
Stopped: Lack of funding
United States199 participantsStarted 2015-10
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.