Report of a collaborative study for assessing the potency of hepatitis B vaccines

Biologicals. 1990 Oct;18(4):345-50. doi: 10.1016/1045-1056(90)90040-7.

Abstract

A collaborative study was carried out to examine the suitability of a hepatitis B vaccine derived from plasma as an immunogenicity reference for vaccines produced by recombinant DNA technology in yeast. The use of a plasma derived vaccine as reference appeared satisfactory, although the use of homologous reference improved agreement in potency estimates. The use of a recombinant standard did not however improve agreement for a recombinant vaccine produced by a different manufacturer. The variation in the dilution of vaccine required to induce antibodies in 50% of test animals and in potency estimates varied widely between laboratories (25-fold and 10-fold respectively). However this was similar to the variation found in a previous collaborative study.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Hepatitis B Antibodies / analysis
  • Hepatitis B Antibodies / biosynthesis
  • Hepatitis B virus / immunology*
  • Mice
  • Reference Standards
  • Vaccines, Synthetic / administration & dosage
  • Vaccines, Synthetic / standards
  • Viral Hepatitis Vaccines / standards*

Substances

  • Hepatitis B Antibodies
  • Vaccines, Synthetic
  • Viral Hepatitis Vaccines