Division of Bacteriology, National Institute for Biological Standards and Control, Blanche Lane, Potters Bar, Hertfordshire, EN6 3QG, UK.
Division of Bacteriology, National Institute for Biological Standards and Control, Blanche Lane, Potters Bar, Hertfordshire, EN6 3QG, UK.
Biologicals. 2021 Apr;70:53-58. doi: 10.1016/j.biologicals.2021.01.001. Epub 2021 Jan 29.
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.
脑膜炎球菌多糖蛋白结合疫苗的效力依赖于多糖含量以预防脑膜炎。NIBSC 作为英国的官方国家对照实验室，使用已建立的国际标准品（脑膜炎奈瑟菌血清 A、C、W、Y 和 X），通过间苯二酚或 HPAEC-PAD 分析了十种不同的单价和多价脑膜炎球菌结合疫苗。考虑到不同的 O-乙酰化水平，大多数糖含量与其许可的声称含量在±20%范围内，只有两种疫苗中的 MenC 含量低于（分别为 60%和 54%）标签值，但之前的研究表明，不同的剂量不一定与这些疫苗的免疫原性相关。本研究证明了使用国际标准品来定量多糖基疫苗中的多糖含量，这些疫苗具有不同的 O-乙酰化百分比。这些国际标准品适合作为定量标准或内部标准的校准品，提供稳定性数据。
