Validation of a routine opsonophagocytosis assay to predict invasive pneumococcal disease efficacy of conjugate vaccine in children

被引:81
作者
Henckaerts, Isabelle [1 ]
Durant, Nathalie [1 ]
De Grave, Dany [1 ]
Schuerman, Lode [1 ]
Poolman, Jan [1 ]
机构
[1] GlaxoSmithKline Biol, Res & Dev, B-1330 Rixensart, Belgium
关键词
pneumococcal conjugate vaccine; opsonophagocytic antibodies; assay validation;
D O I
10.1016/j.vaccine.2006.09.029
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Immunological evaluation of the clinical impact of vaccines designed to protect against infection by Streptococcus pneumoniae requires measurement of serotype-specific functional antibodies. We describe the development and validation of a viable pneumococcal opsonophagocytosis assay (OPA) that can be used for routine serological analysis of paediatric immune responses after immunization. OPA seropositivity (% >= 8 threshold) reflected well invasive pneumococcal disease (IPD) effectiveness. In contrast, the 22F inhibition ELISA seropositivity (% >= 0.20 mu g/ml threshold) overestimated (19F) or underestimated (6B, 23F, 6A) IPD effectiveness for several serotypes. The seropositivity as estimated by a standardized and highly reproducible OPA was predictive for the serotype-specific IPD efficacy of pneumococcal conjugate vaccines. (C) 2006 Published by Elsevier Ltd.
引用
收藏
页码:2518 / 2527
页数:10
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