Clinical trial NCT02601690: Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Allergy
Keywords: Rye Grass
Ragweed
Cat
House Dust Mite
Lead sponsor: Adiga Life Sciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Circassia Limited
First posted: 2015-11-10
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of subjects aged from 18 to 65 years, with a documented history of allergy to one or more of the following: cat, short ragweed, Rye grass, or House Dust Mite.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of T cell responses to SPIREs
timeFrame: 2 years
Secondary outcomes:
measure: Characterization of the distribution of allergen sensitivity across a broad range of common allergens
timeFrame: 2 years
Other outcomes:
Locations:
city: Upland
country: United States
facility: Empire Clinical Research
state: California
city: Fairfax
country: United States
facility: O&O Alpan
state: Virginia
Study officials:
References: