Saccharide dosage content of meningococcal polysaccharide conjugate vaccines determined using WHO International Standards for serogroup A, C, W, Y and X polysaccharides. (April 2021)

• Record Type: Journal Article
• Authors: Gao, Fang; Beresford, Nicola; Lockyer, Kay; Burkin, Karena; Rigsby, Peter; Bolgiano, Barbara
• Is Part Of: Biologicals. Volume 70(2021)
• Page Start: 53
• Page End: 58
• Publication Date: 2021-04
• Subjects: Meningococcal polysaccharide -- Conjugate vaccine -- International standards -- Saccharide content; Biological products -- Standards -- Periodicals; Biological Products -- Periodicals; Biological Products -- standards -- Periodicals; Produits biologiques -- Normes -- Périodiques; Biological products -- Standards; Periodicals; 615.37
• DOI: 10.1016/j.biologicals.2021.01.001
• Languages: English
• ISSNs: 1045-1056

Abstract

Abstract: 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.