Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- HIA titers 4 weeks after influenza vaccination
研究概览
简要总结
The purpose of this study is to test the specific humoral response after an intramuscular and intradermal influenza vaccination in lung transplant recipients
详细描述
Influenza virus is an important cause of morbidity in the lung transplant population and can lead to viral and bacterial pneumonia and contribute to the bronchiolitis obliterans syndrome. Although the annual influenza vaccine is recommended for lung transplant patients, studies have shown that a single intramuscular (i.m.) dose has poor immunogenicity. There are no studies that define the effect of intradermal doses in this population. We plan to study the immunogenicity of a two-dose regimen of influenza vaccine in 50 lung transplant patients during the 2006-2007 season. After the initial i.m. injection, a second dose will be given intradermally 4 weeks later. Antibody titers will be evaluated by a standard hemagglutination inhibition assay. We hypothesize that the second dose intradermally will significantly increase the proportion of vaccine responders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lung transplant recipients greater than 3 months post-transplant
排除标准
- •· Egg allergy
- •Previous life-threatening reaction to influenza vaccine (ie Guillain Barre Syndrome)
- •On anticoagulants such as warfarin that precludes intramuscular injection
- •Ongoing therapy for rejection
- •Febrile illness in the past two weeks
- •Unable to provide informed consent
结局指标
主要结局
HIA titers 4 weeks after influenza vaccination
次要结局
- Local and systemic adverse events to vaccination and rates
- of allograft rejection in the 6 months following vaccination