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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02601690

Enrollment

199

Registered

2015-11-10

Start date

2015-10-31

Completion date

2017-06-25

Last updated

2019-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Keywords

Rye Grass, Ragweed, Cat, 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.

Interventions

OTHERBlood Sampling

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Evaluation of T cell responses to SPIREs	2 years

Secondary

Measure	Time frame
Characterization of the distribution of allergen sensitivity across a broad range of common allergens	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026