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Article Title

Preparation of Hepatitis B Vaccine Reference Standard for Potency Test

Abstract

A well qualified plasma derived hepatitis B vaccine, coded 028A, was evaluated in the National Laboratories of Foods and Drugs for its potency to serve as the first national reference standard for hepatitis B vaccine for use in immunogenicity assays. This proposed national reference standard was assayed against the WHO plasma-derived hepatitis B reference standard, lot 96932. The relative potencies of lot 028A plasma-derived hepatitis B vaccine versus WHO lot 96932 vaccine was evaluated in a series of immunization studies for both guinea pig and Balb/c mouse groups by the parallel line assay method.Results obtained indicated that the relative potencies for the guinea pig and mouse groups were 1.04 ± 0.12 and 1.09 ± 0.39, respectively. This reference standard is intended for use in assays of hepatitis B vaccines in both mouse or guinea pig immunogenicity studies for the vaccine sealing tests in Taiwan.

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