Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine in Children With Liver Disease
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:
- the time at which VZV DNA becomes undetectable in blood and saliva by PCR after vaccination in children with chronic liver disease and
- 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
- 是
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
