Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 493
- 试验地点
- 1
- 主要终点
- antibody titer to hepatitis A vaccine
研究概览
简要总结
The purpose of this study is to measure the immune response in 18-40 year old IBD patients after receiving the hepatitis A vaccine.
详细描述
The spread of hepatitis A has prompted the need for vaccination against this virus. It is uncertain that IBD patients can achieve a truly protective response after vaccination. The efficacy and safety of hepatitis A vaccination have not been evaluated in this population of patients. We would like to estimate the efficacy and safety of vaccination against hepatitis A in patients with IBD.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from inflammatory bowel disease: Crohn's disease/Ulcerative colitis
- •Willing to provide informed consent
排除标准
- •Have history of vaccination to hepatitis A
- •Have other autoimmune disease
- •Have any malignancy
- •Have acute infectious disease
- •Unwilling to provide consent
研究组 & 干预措施
IBD patients
Patients diagnosed with IBD
-> receive Epaxal Berna (virosomal hepatitis A vaccine)
干预措施: Epaxal Berna (virosomal hepatitis A vaccine) (Biological)
结局指标
主要结局
antibody titer to hepatitis A vaccine
时间窗: Month 7
次要结局
- vaccine-associated adverse events and side effects(within the first 30 days after second vaccination)
- vaccine-associated adverse events and side effects(within the first 30 days after first vaccination)
研究者
Suk-Kyun Yang
Professor
Asan Medical Center