International collaborative study for establishment of the 2nd WHO International Standard for Haemophilus influenzae type b polysaccharide

Biologicals. 2015 Nov;43(6):492-503. doi: 10.1016/j.biologicals.2015.07.006. Epub 2015 Aug 19.

Abstract

In this report we present the results of a collaborative study for the preparation and calibration of a replacement International Standard (IS) for Haemophilus influenzae type b polysaccharide (polyribosyl ribitol phosphate; 5-d-ribitol-(1 → 1)-β-d-ribose-3-phosphate; PRP). Two candidate preparations were evaluated. Thirteen laboratories from 9 different countries participated in the collaborative study to assess the suitability and determine the PRP content of two candidate standards. On the basis of the results from this study, Candidate 2 (NIBSC code 12/306) has been established as the 2nd WHO IS for PRP by the Expert Committee of Biological Standards of the World Health Organisation with a content of 4.904 ± 0.185mg/ampoule, as determined by the ribose assays carried out by 11 of the participating laboratories.

Keywords: Haemophilus influenzae b; International standard; Polysaccharide.

Publication types

  • Comparative Study
  • Multicenter Study

MeSH terms

  • Bacterial Capsules / chemistry
  • Biological Assay / standards
  • Calibration
  • Chromatography, High Pressure Liquid
  • Drug Stability
  • Haemophilus Vaccines / chemistry
  • Haemophilus Vaccines / standards
  • Haemophilus influenzae type b / chemistry*
  • Hydrogen-Ion Concentration
  • International Cooperation
  • Laboratories / standards
  • Phosphorus / analysis
  • Polysaccharides / analysis
  • Polysaccharides / standards*
  • Polysaccharides, Bacterial / analysis
  • Polysaccharides, Bacterial / standards*
  • Reference Standards
  • Reproducibility of Results
  • Ribose / analysis
  • World Health Organization*

Substances

  • Haemophilus Vaccines
  • Haemophilus influenzae type b polysaccharide vaccine
  • Polysaccharides
  • Polysaccharides, Bacterial
  • Phosphorus
  • polyribitol phosphate
  • Ribose