Tint H, Rosanoff E I
Dev Biol Stand. 1978;40:195-201.
Two procedures for evaluating the potency of diploid-cell rabies vaccine (WRV) were compared by mouse-serum neutralization (MNT) and RFFIT serological determinations, using NIH Reference Rabies Vaccine No. 182 as base. Mean antibody-induction potency value ratios in female CD1 mice for 12 WRV assays were 5.12 by MSN and 4.57 by RFFIT compared with a 2.84 Antigen Value by the standard 28-day NIH mouse neutralization tests on the same lots. The mean antibody-induction potency values for 12 control DEV preparations were 0.71 (MSN) and 0.81 (RFFIT) versus 0.51 Antigen Value by NIH test. The statistical parameters of all respective means were similarly compared. MRV potencies of the order of magnitude shown correlated well with superior human immunogenicity but not linearly over a ten-fold range of antigen values from about 1 to 10. MNT antibody responses were 15-30 I.U. per ml of serum to WRV in this range (3-dose immunization); corresponding overall RFFIT values were 8 to 15 I.U. per ml. Control immunizations with DEV preparations yielded immune responses approximately one order of magnitude lower under comparable conditions.
以美国国立卫生研究院（NIH）第182号狂犬病参考疫苗为基础，通过小鼠血清中和试验（MNT）和快速荧光灶抑制试验（RFFIT）血清学测定，比较了两种评估二倍体细胞狂犬病疫苗（WRV）效力的方法。在12次WRV检测中，雌性CD1小鼠的平均抗体诱导效力值比，通过MSN为5.12，通过RFFIT为4.57，而同一批次的标准28天NIH小鼠中和试验的抗原值为2.84。12种对照DEV制剂的平均抗体诱导效力值，通过MSN为0.71，通过RFFIT为0.81，而NIH试验的抗原值为0.51。对所有各自的平均值的统计参数进行了类似的比较。所示数量级的MRV效力与卓越的人类免疫原性相关性良好，但在约1至10的十倍抗原值范围内并非呈线性关系。在此范围内（3剂免疫），MNT抗体反应为每毫升血清15 - 30国际单位（I.U.）针对WRV；相应的总体RFFIT值为每毫升8至15国际单位。在可比条件下，用DEV制剂进行对照免疫产生的免疫反应低约一个数量级。
