Essential criteria for evaluation of pneumococcal conjugate vaccine candidates

被引：16
|
作者：
Paradiso, Peter [1 ]
机构：
[1] Wyeth Pharmaceut, Wyeth Vaccines, Collegeville, PA 19426 USA
来源：
VACCINE | 2009年 / 27卷
关键词：
PCV7; Correlate of immunity; ELISA; ANTIBODY-RESPONSE; CHILDREN; POLYSACCHARIDE; EFFICACY; IMPACT; IMMUNOGENICITY; PNEUMONIA; INFANTS; TRIAL;
D O I：
10.1016/j.vaccine.2009.06.008
中图分类号：
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号：
100102 ;
摘要：
In 2003, the World Health Organization recommended a concentration of enzyme-linked immunosorbent assay (ELISA) immunoglobulin G (IgG) anti-capsular antibody of 0.35 mu g/mL as a reference value that correlates to protection against invasive pneumococcal disease. This threshold can be used to demonstrate immunologic non-inferiority of a new vaccine in comparison trials that use pneumococcal conjugate vaccines (PCVs) as a comparator. An investigational 13-valent PCV (PCV13) compared with seven-valent PCV (PCV7) demonstrated that all of the pneumococcal serotypes contained in PCV13 were immunogenic, with 88-98% of vaccinees achieving antibody concentration >= 035 mu g/mL for serotypes shared with PCV7 and >96% for six additional serotypes. (C) 2009 Elsevier Ltd. All rights reserved.
引用
收藏
页码：C15 / C18
页数：4
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