Comparison of Immune Response in Pneumococcal Pneumonia and After Vaccination
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 8
- 主要终点
- Expression of homing receptors on circulating plasmablasts in Pnc pneumonia and after vaccination
研究概览
简要总结
Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia. The study aims to compare lymphocyte homing in pneumonia and in those receiving Pnc polysaccharide vaccine (PPV) or Pnc conjugate vaccine (PCV)
详细描述
Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia. The study compares the homing profiles of Pnc-specific plasmablasts in 15 patients with pneumonia and in 15 volunteers receiving Pnc polysaccharide vaccine (PPV) and 12 volunteers receiving Pnc conjugate vaccine (PCV)
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ≥ 18 and <65 years of age.
- •General good health.
- •Written informed consent.
- •No previous vaccination against Pnc
- •No previous history of Pnc pneumonia
- •In pneumonia: Diagnosis of Pnc pneumonia within a week
排除标准
- •< 18 years, ≥65 of age.
- •In vaccinees: Acute disease at the time of enrollment.
- •Pregnancy or lactation.
- •Known immunodeficiency or immune suppressive treatment.
- •Any chronic illness that might interfere with the immune response
- •Alcohol or drug abuse
- •Any clinically significant history of known or suspected anaphylaxis or hypersensitivity (based on the investigator's judgement).
结局指标
主要结局
Expression of homing receptors on circulating plasmablasts in Pnc pneumonia and after vaccination
时间窗: Day 0 and Day 7-10
HR on circulating Pnc-specific plasmablasts are determined in patients with pneumonia on day 7-10, in vaccinees on days 0 and 7
次要结局
未报告次要终点