1. Evaluation of candidate international standards for meningococcal serogroups A and X polysaccharide
- Author
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Fang Gao, Peter Rigsby, Caroline Vipond, Thomas Dougall, Nicola J. Beresford, Carolyn Swann, and Barbara Bolgiano
- Subjects
0301 basic medicine ,Quantitative nmr ,Meningococcal Vaccines ,Bioengineering ,Meningococcal vaccine ,medicine.disease_cause ,Applied Microbiology and Biotechnology ,Expert committee ,Microbiology ,03 medical and health sciences ,0302 clinical medicine ,Neisseria meningitidis, Serogroup A ,medicine ,Humans ,030212 general & internal medicine ,Food science ,Pharmacology ,General Immunology and Microbiology ,business.industry ,Neisseria meningitidis ,Polysaccharides, Bacterial ,General Medicine ,030104 developmental biology ,Coverage factor ,business ,Biotechnology - 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.
- Published
- 2017