跳至主要内容
临床试验/NCT01353989
NCT01353989已完成不适用

Hepatitis A Vaccination in the Elderly

Rijnstate Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
How fast do patients> 60 year reach protective anti-HAV levels after vaccination?

研究概览

简要总结

A lot of elderly people travel to hepatitis A endemic areas. The prevalence of hepatitis A IgG positivity is declining in the Netherlands, also in the elderly. Studies show that people above 40 years of age have a slower immune response to hepatitis A vaccination. However, a lot of travelers seek pre-travel advice only shortly before their journey. More information about the time to adequate antibody response after hepatitis A vaccination is required to provide good protection during travelling. Alternative protection with immunoglobulins are available.

Study design: Observational, longitudinal pilot study Study population: 20 adults over 60 years of age with a negative hepatitis A IgG, (with a estimated 50% positivity for hepatitis A IgG in this age Group, 40 patients in this age group) 20 adults 18-40 years of age as controls.

Intervention (if applicable): When hepatitis A vaccination is indicated and informed consent is obtained, hepatitis A IgG wil be measured at day 0, 7, 14, 21 en 28.

Main study parameters/endpoints: Time to protective hepatitis A IgG. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: hepatitis A vaccination will be given also outside this study. In the study 5 venous punctures of 7 ml of blood.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • previous hep A vaccination
  • known hepatitis A serology status
  • immunodeficiency

结局指标

主要结局

How fast do patients> 60 year reach protective anti-HAV levels after vaccination?

时间窗: 0, 1,2,3,4 weeks

次要结局

未报告次要终点

研究者

发起方
Rijnstate Hospital
申办方类型
Other

研究点 (1)

Loading locations...

相似试验