Serological Response to Pneumococcal Vaccination in Crohn's Disease: A Prospective Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 15
- 主要终点
- Serological response rates
研究概览
简要总结
A growing number of patients with Crohn's disease are treated with immunosuppressive agents, such as anti-tumor necrosis factor blockers and immunomodulators. Several recent studies have indicated that immunosuppressive treatment may impair the immunological response to pneumococcal vaccination in patients with inflammatory bowel disease (Crohn's disease and Ulcerative colitis). One of weaknesses in the previous studies did not focus on specific disease, such as Crohn's disease. In addition, predictive factors affecting impaired response following pneumococcal vaccination have not clearly evaluated in patients with Crohn's disease. In this study, patients with Crohn's disease will be assessed for serological response to pneumococcal vaccination. Further, potential predictive factors that impact on vaccination outcomes and adverse events related to vaccination will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 18
- •Informed consent
- •Patients who had a definitive diagnosis of Crohn's disease for more than 6 months (documented by the standard clinical, radiographic, endoscopic, and histopathologic criteria)
排除标准
- •Hypersensitivity to any component of the pneumococcal vaccine
- •Known allergy to pneumococcal vaccination
- •Patients who treated with glucocorticoids (prednisolone > 20 mg/day equivalent for 2 weeks or more, and within 3 months of stopping
- •Patients who inoculate another vaccine in the past 4 weeks
- •Significant protein calorie malnutrition
- •Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, infectious, neurologic or cerebral disease
- •Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
研究组 & 干预措施
anti-TNF only
Crohn's disease, on an anti-TNF agent [infliximab or adalimumab] only
干预措施: 23-valent polysaccharide pneumococcal vaccine (Drug)
Combined immunosuppression
Crohn's disease, on combined immunosuppression (both anti-TNF agent and immunomodulator [azathioprine or 6-MP])
干预措施: 23-valent polysaccharide pneumococcal vaccine (Drug)
Immunomodulator only
Crohn's disease, on an immunomodulator only
干预措施: 23-valent polysaccharide pneumococcal vaccine (Drug)
Non-immunosuppression
Crohn's disease, not on immunosuppressive medications (5-ASA only: control arm)
干预措施: 23-valent polysaccharide pneumococcal vaccine (Drug)
结局指标
主要结局
Serological response rates
时间窗: 4 weeks
Serological response rates, defined by number of patients showing adequate response to pneumococcal vaccination (at least a 2-fold increase in antipneumococcal antibodies in the serum compared with baseline)
次要结局
- Safety assessment of the vaccine(8 weeks)
研究者
Chang Kyun Lee
Assistant Professor
Kyunghee University Medical Center