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ACYW135群脑膜炎球菌结合疫苗在小鼠中的安全性和免疫原性研究

  • 王婷婷 李亚楠 任涛 郝倩 张明华 唐秀丽 魏文进 郑海发
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  • 102600 北京民海生物科技有限公司研发部(王婷婷、任涛、郝倩、张明华、唐秀丽、魏文进、郑海发);100050 北京,中国食品药品检定研究院菌种室(李亚楠)

网络出版日期: 2025-08-16

基金资助

国家高科技研究发展计划(2012AA02A403)

Safety and immunogenicity of groups A,C,Y and W135 meningococcal conjugate  vaccine in mice model

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  • *R&D Center, Beijing Minhai Biotechnology Co., Ltd., Beijing 102600, China

Online published: 2025-08-16

摘要

 目的   研究ACYW135群脑膜炎球菌结合疫苗(groups A,C,Y and W135 meningococcal conjugate vaccine,MCV)在小鼠中的安全性及免疫原性。 方法   用4价MCV腹腔注射BALB/c小鼠,并于接种前及接种后7 d称量小鼠体重,观察小鼠的体重变化。分别于0和14 d用4价MCV皮下免疫BALB/c小鼠,并分别于第1剂接种后7和21 d采血,用间接ELISA测定血清特异性抗体水平。采用成组t检验对实验结果进行统计分析。 结果   在7 d观察期间,所有小鼠的体重均增加,4价MCV接种小鼠与对照小鼠体重增加间的差异无统计学意义(t=1.988,P>0.05)。100% 4价MCV接种小鼠的抗各群多糖抗体阳转,且抗体水平随接种次数的增加而提高。4价MCV接种小鼠与相应的单价疫苗原液接种小鼠的血清抗A群(t=2.107,P>0.05)、C群(t=1.343,P>0.05)、Y群(t=1.648,P>0.05)和W135群(t=0.556,P>0.05)抗体水平间的差异无统计学意义。 结论   4价MCV在小鼠中具有良好的安全性和免疫原性。

本文引用格式

王婷婷 李亚楠 任涛 郝倩 张明华 唐秀丽 魏文进 郑海发 . ACYW135群脑膜炎球菌结合疫苗在小鼠中的安全性和免疫原性研究[J]. 国际生物制品学杂志, 2014 , 37(4) : 157 -160 . DOI: 10.3760/cma.j.issn.1673-4211.2014.04.001

Abstract

 Objective  To study the safety and immunogenicity of a groups A,C,Y and W135 meningococcal conjugate vaccine (MCV) in mice.   Methods   BALB/c mice were injected intraperitoneally with the tetravalent MCV and body weights of mice were measured before and 7 days after injection. BALB/c mice were injected subcutaneously with the tetravalent MCV on day 0 and 14, and blood was collected 7 and 21 days after first dose. Levels of serum antibodies against each polysaccharide were detected using indirect ELISA. The statistical analysis of the results were made by group t test.  Results   In the 7 days observation period, body weights of mice all increased, and weight gains had no significant difference between mice immunized with the tetravalent MCV and control mice (t=1.988, P>0.05). Serum conversion rates of antibodies against each polysaccharide were 100% in mice immunized with the tetravalent MCV, and levels of serum antibodies against each polysaccharide increased with the increase of injection times. Levels of serum antibodies against group A (t=2.107, P>0.05), group C (t=1.343, P>0.05), group Y (t=1.648, P>0.05) and group W135 (t=0.556, P>0.05) had no significant difference between mice immunized with the tetravalent MCV and relevant monovalent vaccine bulk.  Conclusion   The tetravalent MCV has good safety and immunogenicity in mice.
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