NCT00492739招募中2 期
Induction and Maintenance of Immunity Against Varicella in Pediatric Orthotopic Liver Transplantation Recipients: a Retrospective and Prospective Nationwide Study in Switzerland
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Safety of VZV vaccine in OLTx recipients
研究概览
简要总结
Varicella is a vaccine-preventable disease, which can be severe in immunosuppressed children. Currently, the (live) vaccine is not recommended in pediatric orthotopic liver transplant recipients. Furthermore, protection due to naturally acquired immunity to VZV or post-immunization isn't well described in this population.The questions asked are:
- What is the influence of the immunosuppression required after orthotopic liver transplantation (OLT) on the maintenance of VZV-specific immunity elicited by wild-type varicella infection before OLT transplantation?
- What is the influence of the immunosuppression required after OLT on VZV-specific immunity elicited by varicella immunization before OLT transplantation?
- What is the influence of the residual immunosuppression at ≥ 12 months after OLT transplantation on the induction of VZV-specific B and T cell responses elicited by VZV vaccination after OLT transplantation?
- What is the influence of the residual immunosuppression at ≥ 12 months after OLT transplantation on the persistence / waning of B and T cell responses elicited by VZV vaccination?
详细描述
VZV vaccine given to pediatric liver transplant recipients at least one year after transplantation if tehy fulfill inclusion criteria and give informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children either awaiting or recipients of a liver transplantation followed at the Children's Hospital of Geneva, Switzerland
- •If vaccination offered: > 12 months of age
排除标准
- •Known wild type varicella exposure within four weeks of the initial vaccine
- •Immunoglobulins administered within the 5 months preceding the receipt of varicella vaccine.
- •Antiviral agents administered during the preceding 4 weeks
- •Febrile illness (>38.5°) in the 72 hours before vaccine administration
- •Chronic aspirin therapy
- •Any other live vaccinations within four weeks of receipt of varicella vaccine
- •Female patients in childbearing age will have a pregnancy test at enrollment, and at the time of the second vaccine.
结局指标
主要结局
Safety of VZV vaccine in OLTx recipients
时间窗: 2 years
Antibody response measured after vacination with long-term f/u
次要结局
- Efficacy of VZV vaccine in immunosuppressed OLTx recipients(3 years)
研究者
Klara M. Pósfay Barbe
Head of Pediatric Infectious Diseases
University Hospital, Geneva
研究点 (2)
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