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临床试验/NCT01346007
NCT01346007Unknown4 期

Study of Safety, Immunogenicity and Immunological Memory of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome

National and Kapodistrian University of Athens1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
50
试验地点
1
主要终点
Pneumococcal serotype-specific antibodies and B memory cells

研究概览

简要总结

The purpose of this study is to determine whether 7-valent pneumococcal conjugate vaccine safely induces immune responses and immunological memory in children with idiopathic nephrotic syndrome in remission.

详细描述

Idiopathic nephrotic syndrome (INS) is the most frequent glomerular disease in children under 16 years old with incidence rate 2-7/100,000 patients/year depending on ethnicity. Those patients are susceptible to invasive pneumococcal disease (IPD) including peritonitis, pneumonia with or without pleural effusion and meningitis. Due to increased mortality and risk of relapses associated with IPD, it has been recommended that children with INS should be immunized with pneumococcal conjugate vaccine [1]. However, concerns on vaccine safety and impaired immunogenicity due to INS pathogenesis and immunosuppressive treatment are a hurdle for universal implementation of existing guidelines.

To thoroughly evaluate safety of 7-valent pneumococcal conjugate vaccine (PCV7) in children with INS in remission, we will investigate a possible association of vaccination with increased risk for recurrences of INS. We will also study immunogenicity and kinetics of immune response in INS patients and healthy subjects and the effect of different types of treatment on primary immune response and antibody persistence at 12-14 months following vaccination with PCV7.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
2 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Male or Female
  • •Between 2-20 years of age

排除标准

  • •serious allergic reaction to previous vaccination
  • •history of invasive pneumococcal disease
  • •vaccination with pneumococcal conjugate vaccine
  • •vaccination with pneumococcal polysaccharide vaccine
  • •administration of intravenous immunoglobulin or other blood products during the last 3 months

研究组 & 干预措施

controls

Active Comparator

干预措施: 7-valent pneumococcal conjugate vaccine (Biological)

patients

Active Comparator

Children with idiopathic nephrotic syndrome in remission treated with low-dose prednisolone and/or mycophenolate mofetil and/or cyclosporine A

干预措施: 7-valent pneumococcal conjugate vaccine (Biological)

结局指标

主要结局

Pneumococcal serotype-specific antibodies and B memory cells

时间窗: Within the first 30 days after vaccination

次要结局

  • Incidence of relapses of idiopathic nephrotic syndrome(Within 12 months after vaccination)

研究者

研究点 (1)

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