A Study of Evaluation Indexes for Antibody Production in Sera After Immunization
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Evaluate the immune response to the pneumococcal polysaccharide vaccine in children, young adults and elderly.
研究概览
简要总结
The aim of this study is to evaluate analytical methods such as ELISA and OPKA that measure the activity of vaccine-induced pneumococcal antibodies. After validation of ELISA and OPKA, pneumococcal antibodies were measured by ELISA and OPKA in paired samples before and after immunization (pneumococcal PS vaccine) in children, adults and elderly.
详细描述
To evaluate the immune response to the pneumococcal polysaccharide vaccine in the elderly, samples from children, young adults and elderly were obtained before and one month after vaccination. The quantitative and qualitative response to the vaccine were measured by the ELISA and opsonophagocytic killing assay for eight vaccine type serotypes (4, 6B, 9V, 14, 18C, 19A, 19F, 23F) and one vaccine-related serotype (6A).
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •elderly subjects over the age 65 years who had not received pneumococcal vaccination
- •adult subjects under the age of 45 years (healthy volunteers with no previous history of pneumococcal vaccination)
- •children subjects over the age of 2 years with no previous history of pneumococcal vaccination
排除标准
- •immunocompromised, asplenia, cancer, liver or renal failure, and history of hypersensitivity to vaccine
研究组 & 干预措施
Pneumococcal polysaccharide vaccine
The immunogenic response to the pneumococcal polysaccharide vaccine was compared between children, adults and elderly.
干预措施: pneumococcal polysaccharide vaccine (Biological)
结局指标
主要结局
Evaluate the immune response to the pneumococcal polysaccharide vaccine in children, young adults and elderly.
时间窗: 1 month after vaccination
次要结局
- Evaluate the immune response to the pneumococcal polysaccharide vaccine with two methods (ELISA and Opsonophagocytic Killing Assay)(1 month after vaccination)