- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01383590
Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis
Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis. Cat-PAD is a novel synthetic, allergen derived peptide desensitizing vaccine currently being developed for the treatment of cat allergy.
At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at the conclusion of therapy. The aim of this study is to identify changes in potential biomarkers after peptide immunotherapy that may be subsequently developed as biomarkers that equate with clinical efficacy.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
- Kingston General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or Female, aged 18-65 years
- A minimum 1-year documented history of rhinoconjunctivitis on exposure to cats.
- Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control.
- Regular exposure to a cat in their normal living or working circumstances throughout the course of the study.
- Minimum qualifying rhinoconjunctivitis symptom scores
Exclusion Criteria:
- History of asthma
- A history of anaphylaxis to cat allergen
- A history of allergen immunotherapy in the previous 10 years, or in the previous 3 years for pre-seasonal immunotherapy treatments
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cat-PAD
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Intradermal injection 1 x 4 administrations 4 weeks apart.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of potential plasma biomarkers of response to peptide immunotherapy
Time Frame: 6 months following last treatment
|
Blood samples derived from the study will be submitted for proteomics analyses aimed at the identification of one or more plasma proteins whose concentration over the course of the study varies in relation to the treatment administered.
The outcome will be determined on the basis of measurements from samples collected over a period commencing prior to treatment and ending 6 months following treatment.
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6 months following last treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptom scores for ocular and nasal symptoms
Time Frame: 4 weeks following treatment
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4 weeks following treatment
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Interleukin production and eosinophil level changes
Time Frame: 4 weeks following treatment
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4 weeks following treatment
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Functional genomic changes
Time Frame: 4 weeks following treatment
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4 weeks following treatment
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Changes in urine metabolomic profiles
Time Frame: 4 weeks following treatment
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4 weeks following treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RES-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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