B型肝炎疫苗效價試驗用標準品之製備   全文下載

Preparation of Hepatitis B Vaccine Reference Standard for Potency Test

本研究報告係敘述本實驗室－－行政院衛生署藥物食品檢驗局－－第一次標定出批號028A血漿B型肝炎疫苗效價試驗用國家標準品之結果。本項標定實驗主要是以世界衛生組織所提供之WHO Lot 96932血漿B型肝炎疫苗標準品為試驗對照標準品，分別以天竺鼠和小鼠為實驗動物，採用通常實施B型肝炎疫苗效價實驗之免疫方法，以平行線定量法計算028A血漿B型肝炎疫苗對WHO Lot 96932血漿B型肝炎疫苗標準品之相對效價。白天竺鼠組和小鼠組之結果顯示本028A批血漿B型肝炎疫苗對WHO Lot 96932標準品之相對效價分別為1.04 ±　0.12 和1.09 ± 0.39，亦即028A批B型肝炎疫苗對WHO Lot 96932 B型肝炎疫苗標準品之相對效價極為接近1.00，而由各項統計學之結果更顯示了028A批B型肝炎疫苗足以當作本局今後進行各項B型肝炎疫苗封緘檢驗時之B型肝炎疫苗效價試驗用對照標準品。

A well qualified plasma derived hepatitis B vaccine, cooed 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.