Evaluation of candidate international standards for meningococcal serogroups A and X polysaccharide. (May 2017)

• Record Type: Journal Article
• Authors: Vipond, Caroline; Swann, Carolyn J.; Dougall, Thomas W.; Rigsby, Peter; Gao, Fang; Beresford, Nicola J.; Bolgiano, Barbara
• Is Part Of: Biologicals. Volume 47(2017)
• Page Start: 33
• Page End: 45
• Publication Date: 2017-05
• Subjects: Neisseria meningitidis -- Meningococcal vaccine -- Group A polysaccharide -- Group X polysaccharide -- International Standard; 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.2017.03.001
• Languages: English
• ISSNs: 1045-1056

Abstract

Abstract: Polysaccharide (PS) based meningococcal vaccines are primarily evaluated by physicochemical methods to ensure batches are consistently manufactured. As PS content is determined by different methods across numerous laboratories, there is a need for International Standards (IS) to calibrate the assays. Following the successful introduction of the WHO Meningococcal group C (MenC) IS in 2011, NIBSC initiated projects to prepare similar standards for groups A, W, Y and X (MenA/W/Y/X) to standardise all meningococcal- PS based vaccines. On the basis of results from a collaborative study to evaluate preparations of MenA and MenX PS, both were established by the WHO Expert Committee on Biological Standardization in Oct 2015 as; the First WHO International Standard for the Meningococcal Group A polysaccharide with a content of 0.845 ± 0.043 mg MenA PS per ampoule (expanded uncertainty with coverage factor of k=2.45 corresponding to a 95% level of confidence); the First WHO International Standard for the Meningococcal Group X polysaccharide with a content of 0.776 ± 0.089 mg MenX PS per ampoule (expanded uncertainty with coverage factor of k=2.45), as determined by quantitative NMR. The standards are available from NIBSC, who act as guardians and distributors of the material under the auspices of WHO.