Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array 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 a change in gene expression over the course of and potentially attributable to Cat-PAD treatment.
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 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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.
- •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
排除标准
- •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)
结局指标
主要结局
Identification of a change in gene expression over the course of and potentially attributable to Cat-PAD treatment.
时间窗: 6 months following treatment
次要结局
- Symptom scores for ocular and nasal symptoms(4 weeks following treatment)
- Interleukin production and eosinophil level changes(4 weeks following treatment)
- Functional genomic changes(4 weeks following treatment)
- Changes in urine metabolomic profiles(4 weeks following treatment)