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Abstract

Seven control laboratories in EC countries participated in a collaborative study, 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. An additional aim of the study was to establish the consistency of assay methods among control laboratories. 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).

Additional information

Authors: FERGUSON M, NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL, HERTS. (GB);HEATH A, NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL, HERTS. (GB);MINOR P D NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL, HERTS. (GB), NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL, HERTS. (GB)
Bibliographic Reference: EUR 12857 EN (1990) 17 PP., MF, ECU 4 THE OFFICE FOR OFFICIAL PUBLICATIONS OF THE EUROPEAN COMMUNITIES, L-2985 LUXEMBOURG
Availability: Can be ordered online
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