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[人用甲型肝炎减毒活疫苗的观察]

[Observation of live, attenuated hepatitis A vaccines in humans].

作者信息

Hu M D

机构信息

Shanghai Hygiene and Anti-epidemic Center.

出版信息

Zhonghua Yu Fang Yi Xue Za Zhi. 1993 Mar;27(2):65-8.

PMID:8394801
Abstract

Hepatitis A viruses L-A-1 and MBB strains were attenuated by serial passages in laboratory, then appropriately attenuated strains were screened based on marmosets experiments. Three live attenuated vaccine lots L-A-1/P14, L-A-1/P21, MBB/P13 (35 degrees C) were prepared respectively. Three vaccine lots titer were 10(5.5), 10(5.0), 10(4.5) TCID50/ml. Each vaccine lot was inoculated into 2 adults and 8 children 1.0 ml intramuscularly in the upper arm. All volunteers were closely observed for 4 weeks after the inoculation: No one showed local or systemic side-effects and serum ALT, ICD were normal. Every body developed anti-HAV 2-3 weeks postinoculation. Anti-HAV IgM also seroconverted. Neutralizing antibody was detected in serum 4-6 months after inoculation. Three vaccine lots showed no significant difference in safety and immunogenicity. The experimental data showed that the live vaccines were safe and had good immunogenicity.

摘要

甲型肝炎病毒L-A-1株和MBB株在实验室中通过连续传代进行减毒,然后基于狨猴实验筛选出适当的减毒株。分别制备了三批减毒活疫苗L-A-1/P14、L-A-1/P21、MBB/P13(35摄氏度)。三批疫苗的滴度分别为10(5.5)、10(5.0)、10(4.5) TCID50/ml。每批疫苗以1.0 ml的剂量在上臂进行肌肉注射,接种于2名成人和8名儿童。接种后对所有志愿者进行了4周的密切观察:无人出现局部或全身副作用,血清谷丙转氨酶(ALT)、肌酸脱氢酶(ICD)均正常。接种后2 - 3周每个人均产生了抗甲型肝炎病毒(anti-HAV)抗体。抗甲型肝炎病毒IgM也发生了血清转化。接种后4 - 6个月在血清中检测到中和抗体。三批疫苗在安全性和免疫原性方面无显著差异。实验数据表明,这些活疫苗是安全的,且具有良好的免疫原性。

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