Prevention of Human Papillomavirus (HPV) Infection in Paediatric Kidney and Liver Transplant Recipients and in Paediatric Patients With Advanced Chronic Kidney Disease: a Prospective, Observational Multi-centre Vaccine Surveillance Study (HPVaxResponse Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Immune Response to HPV vaccine
研究概览
简要总结
Due to their immunosuppressive therapy, solid-organ transplant (SOT) recipients bear a 10 to 100 times higher risk of human papillomavirus (HPV)-associated malignancies than healthy individuals. The objectives of this observational, non-interventional multi-national, multi-centre research project are to gain an insight into current HPV vaccination strategies and to investigate the immune response to different routinely administered HPV vaccines in European paediatric SOT candidates and immunocompromised transplant recipients, enabling patients at risk of vaccination failure to be identified.
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
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paediatric Kidney and/or Liver transplant recipients
- •Paediatric patients with CKD
- •Who receive HPV vaccination according to country-specific vaccine schedule
排除标准
- •No HPV vaccination according to country-specific vaccine schedule
- •No written informed consent
结局指标
主要结局
Immune Response to HPV vaccine
时间窗: Change of immune response from baseline (prior to vaccination) to 4-12 weeks after vaccination and to 18+- 3 months after vaccination will be assessed.
HPV vaccine antibodies
次要结局
未报告次要终点
研究者
PD Dr. med. Britta Hoecker
Privatdozentin Dr. med. Britta Hoecker
University Hospital Heidelberg