Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Identification of potential plasma biomarkers of response to peptide immunotherapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Identification of potential plasma biomarkers of response to peptide immunotherapy
时间窗: 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.
次要结局
- Functional genomic changes(4 weeks following treatment)
- Changes in urine metabolomic profiles(4 weeks following treatment)
- Symptom scores for ocular and nasal symptoms(4 weeks following treatment)
- Interleukin production and eosinophil level changes(4 weeks following treatment)