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作者在52名甲型肝炎病毒(HAV)抗体阴性的健康志愿者中评估了一种新的福马林灭活、以明矾为佐剂的甲型肝炎全病毒疫苗(VAQTA)的免疫原性及耐受性.疫苗病毒从1例感染HAV CR326F株的病人粪便中分离获得,经恒河猴肾细胞(FRhK6)及人二倍体成纤维细胞(MRC-S)连续传代得到足够量的减毒HAV,由化学方法裂解细胞培养液获取病毒,再经聚乙二醇浓缩,高压液相层析纯化至纯度达90%,福马林37℃灭活5天,期间除菌过滤两次.受试者初免剂量为1ml,经三角肌注射,6个月后加强免疫1次.初免后两周,受试者除1人外(98%),抗HAV抗体浓度均超过设定的最低保护水平10IU/L,抗体几何平均浓度(GMC)为165IU/L.4周后受试者100%抗体阳转,抗体GMC增加4倍,达728IU/L.初免后6个月,50名加强免疫的志愿者除1人外(98%),抗HAV抗体均维
The authors evaluated the immunogenicity of a new fammal-inactivated hepatitis A virus vaccine (VAQTA) in 52 healthy volunteers with hepatitis A virus (HAV) antibody negative and Tolerance Vaccine virus was isolated from the stool of a patient infected with the HAV CR326F strain and was serially passaged with rhesus monkey kidney cells (FRhK6) and human diploid fibroblasts (MRC-S) for a sufficient amount of attenuated HAV. The virus was lysed by the chemical method and then concentrated by polyethylene glycol. The purified product was purified by high pressure liquid chromatography to a purity of 90%, and the inulin was inactivated at 37 ° C for 5 days. The initial dose of 1 ml was injected into the deltoid muscle and boosted 6 months later.1 Two weeks after the first immunization, the concentration of anti-HAV antibody exceeded the set limit except for one (98%) of the subjects The protection level was 10 IU / L, the antibody geometric mean concentration (GMC) was 165 IU / L. After 4 weeks, 100% of the subjects were positive for positive antibody and the antibody GMC increased by 4 times to 728 IU / L. After 6 months and 50 Anti-HAV antibodies were maintained in all but one volunteer (98%)