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临床试验/NCT01180699
NCT01180699已完成不适用

A Randomized Controlled Trial Comparing Intradermal vs. Intramuscular Trivalent Inactivated Influenza Vaccine in Adult Solid Organ Transplant Recipients

University of Alberta1 个研究点 分布在 1 个国家目标入组 229 人开始时间: 2010年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
229
试验地点
1
主要终点
Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen

研究概览

简要总结

Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia and contribute to the development of rejection. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that a single intramuscular 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 two different administration routes of the influenza vaccine in 200 solid organ transplant patients during the 2010-2011 season. Patients will be randomized to receive influenza vaccine either intradermally or intramuscularly. We hypothesize that the patients who receive the intradermal influenza vaccine will significantly reach a higher response to the vaccine. This study advances research on the prevention of serious viral infections in transplant recipients. Results from this study have the potential to directly improve patient care. If the use of the intradermal influenza vaccine is successful, this strategy may lead to a significant reduction in burden of disease, hospitalizations, and long-term morbidity.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥ 18 and ≤ 59,
  • •Greater than 3 months post-transplant,
  • •Any solid organ transplant (kidney, liver, heart, lung, pancreas, intestinal or combinations of the aforementioned organs)

排除标准

  • •Has already received influenza vaccination for 2010-2011 season;
  • •Egg allergy,
  • •Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome),
  • •Ongoing therapy for rejection,
  • •Febrile illness in the past two weeks,
  • •Unable to provide informed consent,
  • •Unable to comply with study protocol

研究组 & 干预措施

influenza vaccine - intradermal

Experimental

intradermal versus intramuscular

干预措施: Influenza vaccine: Vaxigrip or Fluviral and Intanza (Biological)

influenza vaccine - intramuscular

Active Comparator

干预措施: Influenza vaccine: Vaxigrip or Fluviral and Intanza (Biological)

结局指标

主要结局

Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen

时间窗: 4 weeks

次要结局

  • Local and systemic adverse events to vaccination(24 hours, 48 hours and 7 days after each vaccination)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deepali Kumar

Assistant Professor of Medicine

University of Alberta

研究点 (1)

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