Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Circassia Limited
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Identification of potential plasma biomarkers of response to peptide immunotherapy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Functional genomic changes(4 weeks following treatment)
- Changes in urine metabolomic profiles(4 weeks following treatment)
- Symptom scores for ocular and nasal symptoms(4 weeks following treatment)
- Interleukin production and eosinophil level changes(4 weeks following treatment)