Immunogenicity and Safety of the 13-valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients That Are 23-valent Pneumococcal Polysaccharide Vaccine Naive and Pre-immunized.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Antibody response after vaccination to involved serotypes measured by OPA and ELISA
研究概览
简要总结
To assess the immunogenicity of the PCV13 (13 valent pneumococcal conjugated vaccine) vaccine as compared to the PPV23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients treated with chronic hemodialysis that are pre-immunized with the PPSV23 vaccine or are PPV23 vaccine naïve by measuring the ELISA and OPA (opsonophagocytic assay) titers after 4 and 52 weeks.
详细描述
The immunogenicity of the PCV13 (13 valent pneumococcal conjugated vaccine) vaccine as compared to the PPV23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients treated with chronic hemodialysis that are pre-immunized with the PPV23 vaccine or are PPV23 vaccine naïve will be measured by ELISA and OPA (opsonophagocytic assay) titers after 4 and 52 weeks.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •they are under chronic dialysis treatment
- •are 50 years or older and not pregnant
- •have no immediate life threatening conditions
- •are not allergic to one of the compounds of the vaccine
- •have a known pneumococcal vaccination status
- •give their informed consent.
排除标准
- •Patients not fulfilling the inclusion criteria.
研究组 & 干预措施
PPV23 naive, PPV23 vaccination
vaccination with PPV-23 in 40 PPV-23 naive patients
干预措施: PPV23 vaccination or PCV13 vaccination (Biological)
PPV23 naive, PCV13 vaccination
vaccination with PCV-13 in 40 PPV-23 naive patients
干预措施: PPV23 vaccination or PCV13 vaccination (Biological)
PPV23 > 4 years ago, PCV13 vaccination
vaccination with PCV-13 in 40 patients that received PPV-23 more than 4 years ago
干预措施: PPV23 vaccination or PCV13 vaccination (Biological)
PPV23 < 4 years, PCV13 vaccination
vaccination with PCV-13 in 40 patients that received PPV-23 less than 4 years ago
干预措施: PPV23 vaccination or PCV13 vaccination (Biological)
结局指标
主要结局
Antibody response after vaccination to involved serotypes measured by OPA and ELISA
时间窗: 52 weeks after vaccination
次要结局
- record of side effects of vaccination(first week after vaccination)
- Antibody response after vaccination to involved serotypes measured by OPA and ELISA(4 weeks after vaccination)
研究者
Vandecasteele Stefaan Johan
Stefaan Johan Vandecasteele, MD, PhD
AZ Sint-Jan AV