The Efficacy and Safety of Vaccination Against Pertussis. Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Immunogenicity of Tdap in patients suffering from rheumatoid arthritis
研究概览
简要总结
Pertussis is an acute respiratory infection caused by Bordetella pertussis. Rates of recent B. pertussis infection between 8%--26% have been reported among adults with cough illness of at least 5 days duration who sought medical care. The CDC recommends vaccinating patients aged 15 to 64 years old, once in 10 years. Although acellular vaccines such as BOOSTRIX have been evaluated in healthy population, the safety and efficacy of this vaccine in patients suffering from rheumatic diseases have not been established.
Study population : 50 Rheumatoid Arthritis (RA) patients and 5 healthy controls
Evaluation : the evaluation will be performed on week 0 and 4-6 weeks later. In terms of safety, the patients will be evaluated according to the Disease Activity Index (DAS). Blood will be drawn at each visit at tested for humoral response to tetanus and pertussis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients suffering from RA
- •Aged 18 to 64 years old
排除标准
- •Active disease requiring a change in drug regimen
- •Known allergy to vaccine
结局指标
主要结局
Immunogenicity of Tdap in patients suffering from rheumatoid arthritis
时间窗: 4-6 weeks after vaccination
Geometric mean titers and individual responses to components of pertussis, tetanus and diphtheria
次要结局
- Safety of Tdap vaccine in RA patients(4-6 weeks after vaccination)