NCT02601690TerminatedNot Applicable
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
Adiga Life Sciences, Inc.2 sites in 1 country199 target enrollmentStarted: October 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 199
- Locations
- 2
- Primary Endpoint
- Evaluation of T cell responses to SPIREs
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Ecologic Or Community
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Evaluation of T cell responses to SPIREs
Time Frame: 2 years
Secondary Outcomes
- Characterization of the distribution of allergen sensitivity across a broad range of common allergens(2 years)
Investigators
Study Sites (2)
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