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 Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis|
- Identification of potential plasma biomarkers of response to peptide immunotherapy [ Time Frame: 6 months following last treatment ] [ Designated as safety issue: No ]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.
- Symptom scores for ocular and nasal symptoms [ Time Frame: 4 weeks following treatment ] [ Designated as safety issue: No ]
- Interleukin production and eosinophil level changes [ Time Frame: 4 weeks following treatment ] [ Designated as safety issue: No ]
- Functional genomic changes [ Time Frame: 4 weeks following treatment ] [ Designated as safety issue: No ]
- Changes in urine metabolomic profiles [ Time Frame: 4 weeks following treatment ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Intradermal injection 1 x 4 administrations 4 weeks apart.