Report of a collaborative study for assessing the potency of hepatitis B vaccines |
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| Authors: | M Ferguson A Heath P D Minor |
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| Institution: | Department of Computing and Statistics, National Institute for Biological Standards and Control, Potters Bar, Herts, U.K. |
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| 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. |
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