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

Cat Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383590
• Other study ID #: RES-003
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2011
• Last updated: January 21, 2014
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cat Allergy

Intervention

Biological:
• Cat-PAD
Intradermal injection 1 x 4 administrations 4 weeks apart.

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Circassia Limited	Adiga Life Sciences, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of potential plasma biomarkers of response to peptide immunotherapy	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.	6 months following last treatment	No
Secondary	Symptom scores for ocular and nasal symptoms		4 weeks following treatment	No
Secondary	Interleukin production and eosinophil level changes		4 weeks following treatment	No
Secondary	Functional genomic changes		4 weeks following treatment	No
Secondary	Changes in urine metabolomic profiles		4 weeks following treatment	No