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Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis

This study has been completed.
Adiga Life Sciences, Inc.
Information provided by (Responsible Party):
Circassia Limited Identifier:
First received: June 23, 2011
Last updated: January 21, 2014
Last verified: January 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 Intervention Phase
Cat Allergy
Biological: Cat-PAD
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis

Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: October 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cat-PAD Biological: Cat-PAD
Intradermal injection 1 x 4 administrations 4 weeks apart.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01383590

Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Circassia Limited
Adiga Life Sciences, Inc.
  More Information

Responsible Party: Circassia Limited Identifier: NCT01383590     History of Changes
Other Study ID Numbers: RES-003
Study First Received: June 23, 2011
Last Updated: January 21, 2014

Keywords provided by Circassia Limited:
Cat allergy
Cat-PAD processed this record on April 24, 2017