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临床试验/NCT02692066
NCT02692066撤回不适用

Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine in Children With Liver Disease

University of Colorado, Denver0 个研究点开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
clearance of viral DNA

研究概览

简要总结

Varicella zoster virus (VZV) can lead to significant morbidity and mortality in transplant recipients. Current recommendations suggest a 4 week waiting period between vaccination and transplantation and consideration of booster immunizations if antibody response does not reach target levels. This four week waiting period can result in delayed transplant, rejection of an optimal organ, or missed opportunity to vaccinate. However, these recommendations are not evidence based.

This is a prospective study to look at the immune response to varicella vaccine in children with chronic liver disease.

Investigators will evaluate:

  1. the time at which VZV DNA becomes undetectable in blood and saliva by PCR after vaccination in children with chronic liver disease and
  2. the difference in humoral and cell mediated immune response to varicella immunization between children with chronic liver disease and healthy children.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Months 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 6 months to 21 years
  • no history of varicella, zoster or prior varicella vaccination

排除标准

  • acute liver failure
  • liver transplant anticipated within 28 days
  • prior history of receiving blood products or immunoglobulin within 5 months prior to vaccination
  • pregnancy
  • immunocompromised status
  • receiving immunosuppressive meds

结局指标

主要结局

clearance of viral DNA

时间窗: 4 weeks

humoral response

时间窗: 4 weeks

cell mediated response

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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