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

Allergy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02601690
• Other study ID #: RES-010
• Status: Terminated
• Start date: October 2015
• Est. completion date: June 25, 2017

Study information

• Verified date: April 2019
• Source: Adiga Life Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 199
• Est. completion date: June 25, 2017
• Est. primary completion date: June 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergy
• Hypersensitivity

Intervention

Other:
• Blood Sampling

Locations

Country	Name	City	State
United States	O&O Alpan	Fairfax	Virginia
United States	Empire Clinical Research	Upland	California

Sponsors (2)

Lead Sponsor	Collaborator
Adiga Life Sciences, Inc.	Circassia Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of T cell responses to SPIREs		2 years
Secondary	Characterization of the distribution of allergen sensitivity across a broad range of common allergens		2 years