Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis
|ClinicalTrials.gov Identifier: NCT01383590|
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : January 22, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Cat Allergy||Biological: Cat-PAD||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Intradermal injection 1 x 4 administrations 4 weeks apart.
- 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.
- Symptom scores for ocular and nasal symptoms [ Time Frame: 4 weeks following treatment ]
- Interleukin production and eosinophil level changes [ Time Frame: 4 weeks following treatment ]
- Functional genomic changes [ Time Frame: 4 weeks following treatment ]
- Changes in urine metabolomic profiles [ Time Frame: 4 weeks following treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383590
|Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 2V7|