Cat Allergy
Conditions
Keywords
Cat allergy, Rhinoconjunctivitis, Immunotherapy, Cat-PAD
Brief summary
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.
Interventions
BIOLOGICALCat-PAD
Intradermal injection 1 x 4 administrations 4 weeks apart.
Sponsors
Adiga Life Sciences, Inc.
Circassia Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of potential plasma biomarkers of response to peptide immunotherapy | 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. |
Secondary
| Measure | 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 |
Countries
Canada
Outcome results
None listed