Study of Safety, Immunogenicity and Immunological Memory of 7-valent Pneumococcal Conjugate Vaccine in Children With Idiopathic Nephrotic Syndrome
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 2
- 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
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)
