Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array 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 desensitising vaccine currently being developed for treatment of cat allergy. At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at the conclusion of therapy. No reliable predictive biomarkers of clinical efficacy currently exist. Identification of surrogate biomarkers of clinical efficacy, would facilitate clinical development of peptide immunotherapy vaccines, in addition to providing an improved understanding of the underlying molecular mechanisms of efficacy, thus providing new leads for therapeutic intervention.

Official Title
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Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array 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. Weight >50 kg. A minimum 1-year documented history of rhinoconjunctivitis on exposure to cats. Positive skin prick test to cat allergen. Subjects must have 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 History of anaphylaxis to cat allergen History of allergen immunotherapy in the previous 10 years, or in the previous 3 years for pre-seasonal immunotherapy treatments 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
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 a change in gene expression over the course of and potentially attributable to Cat-PAD treatment. |  | 6 months following 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