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

NCT02601690 | Terminated

• 1 other identifier: RES-010
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 2

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.

Conditions

Allergy

Keywords

Rye Grass; Ragweed; Cat; House Dust Mite

Outcome Measures

Primary Outcomes (1)

• Evaluation of T cell responses to SPIREs

  2 years

Secondary Outcomes (1)

• Characterization of the distribution of allergen sensitivity across a broad range of common allergens

  2 years

Study Arms (1)

Blood Sampling

Participants allergic to one or more of cat, rye grass, ragweed or house dust mite.

Other: Blood Sampling

Interventions

Blood Sampling OTHER

Blood Sampling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adiga Life Sciences, Inc.: lead
• Circassia Limited: collaborator

Study Sites (2)

Empire Clinical Research

Upland, California, 91786, United States

Location

O&O Alpan

Fairfax, Virginia, 22030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for Peripheral Blood Mononuclear Cells (from whole blood), Immunoglobulin E (from serum), and potential tissue typing (from whole blood).

MeSH Terms

Conditions

Hypersensitivity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 10, 2015
• Study Start: October 1, 2015
• Primary Completion: June 25, 2017
• Study Completion: June 25, 2017
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

US (2)