临床试验/NCT01846923

NCT01846923Unknown4 期

Study of the B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals With Beta-thalassemia Major

Aghia Sophia Children's Hospital of Athens2 个研究点分布在 1 个国家目标入组 37 人开始时间: 2010年10月1日最近更新: 2013年5月6日

适应症

试验速览

阶段: 4 期
发起方
入组人数: 37
试验地点: 2
主要终点: immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether one dose of the 13-valent pneumococcal conjugate vaccine (PCV13) induces immunological memory in asplenic adults and whether previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine influence the cellular immune response to PCV13 in this group.

研究设计

研究类型: Interventional
分配方式: Na
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 60 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•β-thalassemia major
•older than 18 years

排除标准

•no previously recorded allergy to PCV
•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 ELISpot)

时间窗: One month post-PCV13

immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot)

时间窗: one month post PCV13

次要结局

Maintenance of B memory cells three years after PCV13 vaccination(three years after study vaccination)

研究者

发起方

Aghia Sophia Children's Hospital of Athens

申办方类型

Other

责任方

Principal Investigator

主要研究者

Vana Spoulou

Assistant Professor of Paediatrics

Aghia Sophia Children's Hospital of Athens

研究点 (2)

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