The Comparison of Serum Antibody Response to Standard Intramuscular and Half Dose Intradermal Influenza Vaccine in Hemodialysis Patients in Shiraz City in 1388.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- vaccine effectiveness
研究概览
简要总结
The purpose of this study is to determine whether half-dose intradermal influenza vaccine is as immunogenic as standard dose intramuscular vaccine in hemodialysis patients.
详细描述
Hemodialysis patients are at high risk of influenza infection due to suppress immune status.It is recommended to immunize them against influenza annually.in intradermal vaccination antigens directly present to the large numbers of antigen-presenting cells in the skin and it may cause greater immunogenicity than in the intramuscular method. Reduced-dose intradermal influenza vaccine is immunogenic in healthy adult, patients with solid cancer and three groups of immunocompromized patients including Rheumatologic patients treated with anti-TNF, HIV-infected and stem cell transplanted patients.
In this study we compare the efficacy of influenza vaccines in half dose intradermal and standard intramuscular methods among hemodialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under chronic hemodialysis
排除标准
- •history of flu infection in last month
- •history of flu vaccination in 2009
- •hospitalization in last month
- •taking immune suppressants drugs
- •hemodialysis less than twice weekly
结局指标
主要结局
vaccine effectiveness
时间窗: 3 months
serum antibody response measured by ELIZA method time frame:1 and 3 months after vaccination
次要结局
未报告次要终点