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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01383590
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : January 22, 2014
Adiga Life Sciences, Inc.
Information provided by (Responsible Party):
Circassia Limited

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.

Condition or disease Intervention/treatment Phase
Cat Allergy Biological: Cat-PAD Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Cat-PAD Biological: Cat-PAD
Intradermal injection 1 x 4 administrations 4 weeks apart.

Primary Outcome Measures :
  1. 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 :
  1. Symptom scores for ocular and nasal symptoms [ Time Frame: 4 weeks following treatment ]
  2. Interleukin production and eosinophil level changes [ Time Frame: 4 weeks following treatment ]
  3. Functional genomic changes [ Time Frame: 4 weeks following treatment ]
  4. Changes in urine metabolomic profiles [ Time Frame: 4 weeks following treatment ]

Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01383590

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

Responsible Party: Circassia Limited Identifier: NCT01383590     History of Changes
Other Study ID Numbers: RES-003
First Posted: June 28, 2011    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by Circassia Limited:
Cat allergy