Study of the Immunogenicity and Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Adults
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 主要终点
- immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)
研究概览
简要总结
The purpose of this study is to determine the effect of a combined vaccination schedule of the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine (PPV23) on the establishment of immunological memory in HIV-infected adults on ART.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD4 T cell count >200cells/μl
排除标准
- •no previously recorded allergy to PCV, PPV23
- •no intravenous immunoglobulin (IVIG) given within the previous 6 months
- •no other vaccine given within the previous 6 months
结局指标
主要结局
immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)
时间窗: One month post-PCV13, PPV23
immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)
immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)
时间窗: One month post-PCV13, PPV23
immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)
次要结局
未报告次要终点
研究者
Vana Spoulou
Associate Professor of Pediatric Infectious Diseases
Aghia Sophia Children's Hospital of Athens