[基于实验和临床数据对甲型肝炎灭活疫苗Hep-A-in-vac免疫原性的比较研究]

[Comparative study of the immunogenicity of the inactivated hepatitis A vaccine Hep-A-in-vac from experimental and clinical data].

作者信息

Karpovich L G, Kalashnikova T V, Gorbunov M A, Pavlova L I, Bektimirov T A, Maĭdaniuk A G, Sandakhchiev L S, Levina V D, Ermolaeva T N, Rodomazova T A

出版信息

Vopr Virusol. 1995 Nov-Dec;40(6):268-70.

PMID:8686264

Abstract

Comparative analysis of the specific activities of various batches of Hep-A-in-Vac vaccine showed that the immunologic efficacy of the agent directly depended on the content of hepatitis A virus antigen in the vaccine dose. The results of studying the immunogenicity of the agent on volunteers are compatible with the results of experimental studies and indicate that the test of guinea pigs adequately assesses this characteristic. Assessment of the immunogenic properties of Hep-A-in-Vac prepared using improved technology indicates that Russian vaccine injected three times in a dose containing at least 40 U EIA ensures 87.5% seroconversion in adult seronegative volunteers with the mean geometrical titer of antibodies to hepatitis A virus equal to 683 mIU/ml.

摘要

对各批次甲型肝炎疫苗的比活性进行比较分析表明，该制剂的免疫效力直接取决于疫苗剂量中甲型肝炎病毒抗原的含量。在志愿者身上研究该制剂免疫原性的结果与实验研究结果相符，表明豚鼠试验能充分评估这一特性。对采用改进技术制备的甲型肝炎疫苗免疫特性的评估表明，以至少含40 U EIA的剂量对成年血清阴性志愿者注射三次俄罗斯疫苗，可确保87.5%的血清转化率，甲型肝炎病毒抗体平均几何滴度等于683 mIU/ml。