Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cat Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cat-PAD

Group Type EXPERIMENTAL

Cat-PAD

Intervention Type BIOLOGICAL

Intradermal injection 1 x 4 administrations 4 weeks apart

Interventions

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Cat-PAD

Intradermal injection 1 x 4 administrations 4 weeks apart

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes