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OpenTrials
Completed

NCT Number: NCT01383590

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.

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Key information

Conditions

Cat Allergy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cat-PAD

Biological

Intradermal injection 1 x 4 administrations 4 weeks apart.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Adiga Life Sciences, Inc.

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 28, 2011
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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