文章摘要
王丽婵,晁哲,吴燕,骆鹏,卫辰,马霄.无细胞百日咳疫苗抗体活性持久性监管研究[J].中国药事,2019,33(10):1129-1133
无细胞百日咳疫苗抗体活性持久性监管研究
Persistent Regulation Study on Antibodies Activity for Acellular Pertussis Vaccine
投稿时间:2019-04-17  
DOI:10.16153/j.1002-7777.2019.10.008
中文关键词: 无细胞百日咳疫苗  抗体  中和抗体  免疫持久性
英文关键词: acellular pertussis vaccine  antibody  neutralization antibody  antibody persistence
基金项目:国家科技重大专项重大新药创制(编号2018ZX09101001)
作者单位E-mail
王丽婵 中国食品药品检定研究院, 国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室, 北京 102629  
晁哲 中国食品药品检定研究院, 国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室, 北京 102629  
吴燕 中国食品药品检定研究院, 国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室, 北京 102629  
骆鹏 中国食品药品检定研究院, 国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室, 北京 102629  
卫辰 中国食品药品检定研究院, 国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室, 北京 102629 weichen@nifdc.org.cn 
马霄 中国食品药品检定研究院, 国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室, 北京 102629 maxiao421@sina.cn 
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中文摘要:
      目的:比较不同类型无细胞百日咳疫苗免疫小鼠后诱导的抗体应答及其持久性。方法:将来自于3家企业,采用2种不同工艺生产的无细胞百日咳疫苗(组分苗和共纯化苗)按一定比例稀释后分别给3组小鼠皮下接种,0.5 mL/只,于第4周加强免疫,剂量与初免疫相同。于免疫后第4周、第5周、第8周、第12周、第17周、第30周、第40周、第50周和第65周取血,分离血清,检测小鼠血清中抗百日咳抗体IgG水平(抗-PT和抗-FHA)和PT的中和抗体水平,并对其结果进行分析比较。结果:两类疫苗组检测结果比较,在免疫后第30周之前,两组之间抗-PT和抗-FHA水平无显著性差异;但在30周之后,两组之间抗-PT和抗-FHA水平有显著性差异(P < 0.05),组分苗组抗体水平高于共纯化苗组。中和抗体方面,组分苗组中和抗体水平高于共纯化苗组,两组比较有显著性差异(P < 0.05)。结论:两种类型的百日咳疫苗免疫小鼠后均能诱导产生体液免疫应答,组分苗组的抗体持久性(包括百日咳抗体IgG和百日咳PT中和抗体)强于共纯化苗组;且百日咳IgG抗体与中和抗体之间具有一定的相关性。
英文摘要:
      Objective: To compare antibody responses and persistence induced by immunized mice with different types of acellular pertussis vaccine. Methods: The acellular pertussis vaccines from three companies, which were produced by two different processes, were diluted to a certain proportion and then subcutaneously inoculated into three groups of mice, 0.5 mL per mouse, and immunization was strengthened in the fourth week. The dose was the same as the first immunization. The serum was isolated for the detection of levels of antibody IgG (anti-PT and anti-FHA) and PT neutralizing antibody at 4, 5, 8, 12, 17, 30, 40, 50 and 65 weeks after immunization. The results were analyzed and compared. Results: There was no significant difference in the levels of anti-PT and anti-FHA between the two vaccine groups before the 30th week after immunization (P>0.05). However, there was significant difference in the levels of anti-PT and anti-FHA between the two groups after 30th weeks (P< 0.05), the antibody level of component vaccine group was higher than that of co-purified vaccine group. In the neutralization antibody, the neutralization antibody level of the component vaccine group was significantly higher than that of the co-purified vaccine group (P<0.05). Conclusion: Both types of pertussis vaccine could induce humoral immune response by immunization of mice. The antibody persistence of the component vaccine group (including pertussis antibody IgG and PT neutralizing antibody) was stronger than that of the co-purified vaccine group, and there was a certain correlation between the two antibodies.
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