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

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.

Study Overview

• Status: Terminated
• Conditions: Allergy
• Intervention / Treatment: Other: Blood Sampling

• Study Type: Observational
• Enrollment (Actual): 199

Contacts and Locations

Study Locations

• United States
  • California
    • Upland, California, United States, 91786
      • Empire Clinical Research
  • Virginia
    • Fairfax, Virginia, United States, 22030
      • O&O Alpan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Blood Sampling; Participants allergic to one or more of cat, rye grass, ragweed or house dust mite.	Other: Blood Sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of T cell responses to SPIREs	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Adiga Life Sciences, Inc.
• Collaborators: Circassia Limited

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): June 25, 2017
• Study Completion (Actual): June 25, 2017

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: November 9, 2015
• First Posted (Estimate): November 10, 2015

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Cat; House Dust Mite; Ragweed; Rye Grass
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: RES-010