The Establishment of Serotype-specific Immunological Memory Against Pneumococcus by a 3+1 Versus a 2+1 or 3+0 Infant PCV13 Vaccination Schedule
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- switched immunoglobulin G (swIgG) B memory cell response (measured by flow cytometry)
研究概览
简要总结
The purpose of this study is to evaluate the establishment of immunological memory between the 3 different infant vaccination schedules with the 13-valent pneumococcal conjugate vaccine (PCV13) currently in use. We aim to determine the optimal schedule for the establishment of antigen-specific memory B-cell pool, which may serve as a correlate for longevity of immunological memory against vaccine serotypes. Moreover, we will study the transcriptome profiles expressed by peripheral lymphocytes during each immune response in an attempt to reveal immunological mechanisms beyond the antibody and circulating B cells level.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2-15 months of age
排除标准
- •previously recorded allergy to PCV
- •intravenous immunoglobulin (IVIG) given within the previous 6 months
- •primary or secondary immunodeficiency
- •any chronic medical condition
结局指标
主要结局
switched immunoglobulin G (swIgG) B memory cell response (measured by flow cytometry)
时间窗: 28 days post last vaccine dose
phenotype characterisation of swIgG memory B cells pre- and post- last dose of PCV13
immunoglobulin G (IgG) antibody serum titers (measured by ELISA)
时间窗: 28 days post last vaccine dose
measurement of IgG antibody titers in serum pre- and post- last dose of PCV13
immunoglobulin M (IgM) B memory cell response (measured by flow cytometry)
时间窗: 28 days post last vaccine dose
phenotype characterisation of IgM memory B cells pre- and post- last dose of PCV13
次要结局
- Transcriptional profile of Peripheral Blood Mononuclear Cells (PBMC) in response to PCV13 (measured by RNA-Sequencing)(7 days post last vaccine dose)
研究者
Vana Spoulou
Assistant Professor of Paediatrics
Aghia Sophia Children's Hospital of Athens