Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis

Study Overview
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Brief Summary
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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.

Official Title
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Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis

Conditions
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Cat Allergy

Intervention / Treatment
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* Biological: Cat-PAD


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cat-PAD<br> | Biological: Cat-PAD<br>* Intradermal injection 1 x 4 administrations 4 weeks apart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of potential plasma biomarkers of response to peptide immunotherapy | 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. | 6 months following last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom scores for ocular and nasal symptoms |  | 4 weeks following treatment | 
| Interleukin production and eosinophil level changes |  | 4 weeks following treatment | 
| Functional genomic changes |  | 4 weeks following treatment | 
| Changes in urine metabolomic profiles |  | 4 weeks following treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cat allergy, Rhinoconjunctivitis, Immunotherapy, Cat-PAD