当前位置: X-MOL 学术Biologicals › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Saccharide dosage content of meningococcal polysaccharide conjugate vaccines determined using WHO International Standards for serogroup A, C, W, Y and X polysaccharides
Biologicals ( IF 1.5 ) Pub Date : 2021-01-29 , DOI: 10.1016/j.biologicals.2021.01.001
Fang Gao 1 , Nicola Beresford 1 , Kay Lockyer 1 , Karena Burkin 1 , Peter Rigsby 2 , Barbara Bolgiano 1
Affiliation  

Potency of meningococcal polysaccharide-protein conjugate vaccines relies on the polysaccharide content to prevent meningitis. NIBSC, as the official national control laboratory in UK, analysed ten different mono- and multi-meningococcal conjugate vaccines, using established International Standards for meningococcal serogroups A, C, W, Y and X, by resorcinol or HPAEC-PAD assay. Most saccharide contents were within ±20% of their claimed content for licensure with taking different O-acetylation levels into consideration, with only MenC content in two vaccines below (by 60% and 54%) the labelled value, however, previous study showed different dosage was not necessarily correlated to the immunogenicity of those vaccines. This study demonstrated the use of International Standards to quantify saccharide content in polysaccharide-based vaccines with different percentage of O-acetylation. These International Standards are suitable to serve as either quantitative standard or calibrator of in-house standards, with supplied stability data.



中文翻译:

使用 WHO 血清群 A、C、W、Y 和 X 多糖国际标准确定的脑膜炎球菌多糖结合疫苗的糖剂量含量

脑膜炎球菌多糖-蛋白质结合疫苗的效力依赖于预防脑膜炎的多糖含量。作为英国官方的国家控制实验室,NIBSC 使用针对脑膜炎球菌血清群 A、C、W、Y 和 X 的既定国际标准,通过间苯二酚或 HPAEC-PAD 检测分析了十种不同的单脑膜炎球菌结合疫苗。大多数糖类含量在其声称的含量的 ±20% 范围内,以采取不同的O- 考虑到乙酰化水平,只有两种疫苗中的 MenC 含量低于标记值(分别为 60% 和 54%),但是,之前的研究表明,不同的剂量与这些疫苗的免疫原性不一定相关。该研究证明了使用国际标准来量化具有不同O-乙酰化百分比的基于多糖的疫苗中的糖含量。这些国际标准品适合用作定量标准品或内部标准品的校准品,并提供稳定性数据。

更新日期:2021-01-29
down
wechat
bug