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Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array 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: June 10, 2014
Last verified: June 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 desensitising vaccine currently being developed for treatment of cat allergy.

At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at the conclusion of therapy. No reliable predictive biomarkers of clinical efficacy currently exist. Identification of surrogate biomarkers of clinical efficacy, would facilitate clinical development of peptide immunotherapy vaccines, in addition to providing an improved understanding of the underlying molecular mechanisms of efficacy, thus providing new leads for therapeutic intervention.

Condition Intervention Phase
Cat Allergy Biological: Cat-PAD Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array Analysis

Resource links provided by NLM:

Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • Identification of a change in gene expression over the course of and potentially attributable to Cat-PAD treatment. [ Time Frame: 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: May 2014
Primary Completion Date: May 2014 (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.
  • Weight >50 kg.
  • A minimum 1-year documented history of rhinoconjunctivitis on exposure to cats.
  • Positive skin prick test to cat allergen.
  • Subjects must have 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
  • History of anaphylaxis to cat allergen
  • History of allergen immunotherapy in the previous 10 years, or in the previous 3 years for pre-seasonal immunotherapy treatments
  • 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: NCT01383603

Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L9C3N6
Sponsors and Collaborators
Circassia Limited
Adiga Life Sciences, Inc.
  More Information

Responsible Party: Circassia Limited Identifier: NCT01383603     History of Changes
Other Study ID Numbers: RES-004
Study First Received: June 23, 2011
Last Updated: June 10, 2014

Keywords provided by Circassia Limited:
Cat Allergy
Cat-PAD processed this record on September 21, 2017