Clinical trial NCT01383590: Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis
Official title: Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cat Allergy
Keywords: Cat allergy
Rhinoconjunctivitis
Immunotherapy
Cat-PAD
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
First posted: 2011-06-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Identification of potential plasma biomarkers of response to peptide immunotherapy
timeFrame: 6 months following last treatment
Secondary outcomes:
measure: Symptom scores for ocular and nasal symptoms
timeFrame: 4 weeks following treatment
measure: Interleukin production and eosinophil level changes
timeFrame: 4 weeks following treatment
measure: Functional genomic changes
timeFrame: 4 weeks following treatment
measure: Changes in urine metabolomic profiles
timeFrame: 4 weeks following treatment
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
References:
citation: Neighbour H, Soliman M, Steacy LM, Hickey P, Forbes B, Larche M, Ellis AK. The Allergic Rhinitis Clinical Investigator Collaborative (AR-CIC): verification of nasal allergen challenge procedures in a study utilizing an investigational immunotherapy for cat allergy. Clin Transl Allergy. 2018 Apr 12;8:15. doi: 10.1186/s13601-018-0198-7. eCollection 2018.