Colonisation endpoints in Streptococcus pneumoniae vaccine trials

被引：41

作者：

Auranen, Kari ^{[1
]}

Rinta-Kokko, Hanna ^{[1
]}

Goldblatt, David ^{[2
]}

Nohynek, Hanna ^{[1
]}

O'Brien, Katherine L. ^{[3
]}

Satzke, Catherine ^{[4
,5
]}

Simell, Birgit ^{[1
]}

Tanskanen, Antti ^{[1
]}

Kayhty, Helena ^{[1
]}

机构：

[1] Natl Inst Hlth & Welf THL, Dept Vaccinat & Immune Protect, FI-00271 Helsinki, Finland

[2] UCL, Sch Med, Inst Child Hlth, London W1N 8AA, England

[3] Johns Hopkins Bloomberg Sch Publ Hlth, Baltimore, MD USA

[4] Royal Childrens Hosp, Murdoch Childrens Res Inst, Parkville, Vic 3052, Australia

[5] Univ Melbourne, Dept Microbiol & Immunol, Parkville, Vic 3052, Australia

来源：

VACCINE | 2013年 / 32卷 / 01期

关键词：

Nasopharyngeal colonisation; Pneumococcus; Trial endpoint; Vaccine efficacy; PNEUMOCOCCAL CONJUGATE VACCINE; NASOPHARYNGEAL CARRIAGE; EFFICACY; DISEASE; IMMUNOGENICITY; IMMUNIZATION; INFANCY; IMPACT;

D O I：

10.1016/j.vaccine.2013.08.061

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Evaluating vaccine efficacy for protection against colonisation (VEcol) with bacterial pathogens is an area of growing interest. In this article, we consider estimation of VEcol for colonisation with Streptococcus pneumoniae (the pneumococcus). Colonisation is a common, recurrent and multi-type endpoint that requires both careful definition of the vaccine efficacy parameter and the corresponding method of estimation. We review recent developments in the area and provide practical guidelines for choosing the estimand and the estimation method in trials with a colonisation endpoint. We concentrate on methods that are based on a cross-sectional study design, in which only one nasopharyngeal sample is obtained per study subject. (C) 2013 Published by Elsevier Ltd.

引用

页码：153 / 158

页数：6

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