评估肺炎球菌结合疫苗候选物的基本标准。
Essential criteria for evaluation of pneumococcal conjugate vaccine candidates.
作者信息
Paradiso Peter
机构信息
Wyeth Vaccines, Wyeth Pharmaceuticals, 500 Arcola Road, Collegeville, PA 19426, USA.
出版信息
Vaccine. 2009 Aug 21;27 Suppl 3:C15-8. doi: 10.1016/j.vaccine.2009.06.008.
In 2003, the World Health Organization recommended a concentration of enzyme-linked immunosorbent assay (ELISA) immunoglobulin G (IgG) anti-capsular antibody of 0.35 microg/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 > or = 0.35 microg/mL for serotypes shared with PCV7 and >96% for six additional serotypes.
2003年，世界卫生组织推荐将酶联免疫吸附测定（ELISA）免疫球蛋白G（IgG）抗荚膜抗体浓度0.35微克/毫升作为与预防侵袭性肺炎球菌疾病相关的参考值。在以肺炎球菌结合疫苗（PCV）作为对照的比较试验中，该阈值可用于证明新疫苗在免疫学上的非劣效性。一种研究性13价PCV（PCV13）与7价PCV（PCV7）相比，结果显示PCV13中包含的所有肺炎球菌血清型均具有免疫原性，对于与PCV7共有的血清型，88 - 98%的疫苗接种者抗体浓度≥0.35微克/毫升，对于另外六种血清型，该比例>96%。
Zotero 插件