NCT00293904已完成1 期
Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (CYT005-AllQbG10) in Subjects With Seasonal Rhinoconjunctivitis Due to Grass-Pollen Allergy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Nasal Provocation Tests
研究概览
简要总结
The purpose of this study is to evaluate whether the use of a specific immunomodulatory principle (QbG10) together with conventional grass pollen allergen leads to a more rapid and more pronounced decrease of sensitivity against pollen than with the grass pollen allergen alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- 否
入选标准
- •18 to 65 years of age
- •Mild to moderate seasonal allergic rhinoconjunctivitis due to sensitization against grass pollen as evident from history (≥ 2 years), and positive nasal provocation test (NPT) and positive skin prick test (SPT, wheal ≥ 3mm larger than diluent) to grass pollen extract
- •Female participants must meet one of the following criteria:
- •No reproductive potential due to menopause (one year without menses, in case of doubts serum FSH will be determined and must be >40 U/mL), hysterectomy, bilateral oophorectomy, or tubal ligation. Patient agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 1 additional months after the last immunization (hormone-based, or intrauterine device, or double barrier contraception, i.e. condom + diaphragm, condom or diaphragm + spermicidal gel or foam)
- •Written informed consent
- •Patient is willing and able to comply with all trial requirements
排除标准
- •Additional allergies (seasonal or perennial) of which the symptoms overlap temporally with the screening and treatment period
- •Contraindication to Allergen Preparation
- •Contraindication for Nasal Provocation Test
- •Contraindication for Skin Prick Test
- •Actual significant obstructive pulmonary disorder (FEV1< 70%)
- •Pharmacological treatment that could affect allergic sensitivity during the trial
- •Presence or history of significant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological, and psychiatric disease as judged by the investigator
- •Serum test positive for HIV, HBV, or HCV
- •Current diagnosis or history of malignancy; presence of suspicious lymphadenopathy or splenomegaly on physical examination
- •Pregnancy or lactation
- •Blood donation within 30 days before enrolment
- •History of abuse of alcohol or other recreational drugs
- •Specific immunotherapy against pollen allergy within the last two years
- •Intake of an investigational drug within three month before enrolment
- •Intake of contraindicated medicaments for SIT as Betablockers, ACE/ATII Inhibitors
结局指标
主要结局
Nasal Provocation Tests
次要结局
- Allergy and Medication Questionnaires
研究者
研究点 (2)
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