论著

带状疱疹减毒活疫苗安全性及免疫原性评价

  • 石玮 易应磊 刘芬 董金蓉 陈则
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  • 200051 上海生物制品研究所有限责任公司质量检定室(石玮),第四研究室(易应磊、刘芬、董金蓉、陈则)

网络出版日期: 2025-08-16

基金资助

上海市科技支撑项目(16431904500)

Safety and immunogenicity evaluation of live attenuated herpes zoster vaccine

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  • *Quality Inspection Department, Shanghai Institute of Biological Products Co., Ltd., Shanghai 200051, China.

Online published: 2025-08-16

Supported by

The Shanghai Municipal Science and Technology Support Project (16431904500)

摘要

目的  评价带状疱疹减毒活疫苗的临床前安全性及免疫原性。方法  用不同剂量带状疱疹减毒活疫苗皮下接种BALB/c小鼠1或2次,观察接种后的临床症状,并在末次接种后2周采集并分离小鼠血清和脾淋巴细胞。采用荧光抗体膜抗原法和糖蛋白ELISA检测血清抗水痘-带状疱疹病毒抗体水平。用酶联免疫斑点试验检测分泌IFN-γ的T细胞数量。用流式细胞仪检测不同T细胞所占比例。结果  疫苗接种后未见不良反应发生,且小鼠的T细胞平衡未受到影响。无论接种1次还是2次,都能诱导体液和细胞免疫应答,且再次接种后诱导的免疫应答更强。随着免疫剂量的增加,疫苗诱导的免疫应答也随之增强。结论  带状疱疹减毒活疫苗具有较好的安全性和免疫原性。

本文引用格式

石玮 易应磊 刘芬 董金蓉 陈则 . 带状疱疹减毒活疫苗安全性及免疫原性评价[J]. 国际生物制品学杂志, 2017 , 40(6) : 261 -264 . DOI: 10.3760/cma.j.issn.1673-4211.2017.06.001

Abstract

Objective  To evaluate the preclinical safety and immunogenicity of live attenuated herpes zoster (HZ) vaccine. Method  BALB/c mice were immunized subcutaneously with different doses of herpes zoster  vaccine 1 or 2 times. The clinical presentation was observed. The serum and spleen lymphocytes were collected at 2 weeks after last immunization. The antibody against varicella-zoster virus in serum was detected by fluorescent antibody membrane antigen method and glycoprotein ELISA. The numbers of IFN-γ-secreting T cells were detected by enzyme-linked immunospot assay. The frequency of different T cells was measured by flow cytometry. Results  There were no side effects in BALB/c mice with 1 or 2 vaccinations. The balance of T cells was not affected in mice. Humoral and cellular immune responses in mice were induced by both 1 and 2 immunizations, and enhanced by booster injection. The dose of vaccine was correlated with the strength of humoral and cellular immune responses. Conclusion  The live attenuated herpes zoster  vaccine has good safety and immunogenicity.
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