不同方法制备的4型肺炎球菌多糖-白喉类毒素结合物的免疫原性比较 |
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引用本文: | 聂晓齐,李鑫,任涛,唐秀丽,题靖,杨朝晖. 不同方法制备的4型肺炎球菌多糖-白喉类毒素结合物的免疫原性比较[J]. 国际生物制品学杂志, 2019, 42(2): 53-56. DOI: 10.3760/cma.j.issn.1673-4211.2019.02.001 |
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作者姓名: | 聂晓齐 李鑫 任涛 唐秀丽 题靖 杨朝晖 |
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作者单位: | 北京民海生物科技有限公司研发中心 102600;北京民海生物科技有限公司研发中心 102600;北京民海生物科技有限公司研发中心 102600;北京民海生物科技有限公司研发中心 102600;北京民海生物科技有限公司研发中心 102600;北京民海生物科技有限公司研发中心 102600 |
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摘 要: | 目的 比较以1-氰基-4-二甲氨基吡啶四氟硼酸盐(1-cyano-4-dimethylamino pyridine tetrafluoroborate,CDAP)和溴化氰(cyanogen bromide,CNBr)为活化剂制备的4型肺炎球菌多糖(type 4 pneumococcal polysaccharide,PS4)-白喉类毒素(diphtheria toxoid,DT)结合物(PS4-DT)原液的免疫原性。方法 分别以CDAP或CNBr为活化剂,各制备1批PS4-DT原液,并对原液的相关质量指标进行检测。分别用2种PS4-DT原液,间隔2周皮下注射NIH小鼠3次,末次免疫1周后采集血清,用ELISA检测血清抗体水平,比较不同方法制备的2种PS4-DT原液的免疫原性。结果 2种PS4-DT原液的主要质量指标均符合相关规定的要求,结合PS4的含量分别为257.1和203.1 μg/ml。2种PS4-DT原液均可与PS4抗血清发生特异性反应。抑制ELISA检测显示,2种PS4-DT原液对PS4抗血清的抑制率均达到100%。2种PS4-DT原液免疫小鼠产生的抗PS4抗体水平相近,抗体几何平均滴度分别为970.06和844.49。 结论 不同种方法制备的2种PS4-DT原液在小鼠中的免疫原性相似,且均可诱导小鼠产生较高水平的抗体。
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关 键 词: | 链球菌 肺炎 多糖类 细菌 白喉类毒素 |
Immunogenicity comparison of type 4 pneumococcal polysaccharide-diphtheria toxoid conjugates prepared by different methods |
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Affiliation: | R&D Center,Beijing Minhai Biotechnology Co.,Ltd.,Beijing 102600,China |
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Abstract: | Objective To compare the immunogenicity of type 4 pneumococcal polysaccharide (PS4) - diphtheria toxoid (DT) conjugates (PS4-DT) prepared with 1-cyano-4-dimethylamino pyridine tetrafluoroborate (CDAP) and cyanogen bromide (CNBr) as activators. Methods One batch each of PS4-DT bulk was prepared with CDAP or CNBr as activator, and the relevant quality indexes of 2 PS4-DT bulks were detected. NIH mice were given 3 subcutaneous injections with either of PS4-DT bulks every 2 weeks. The mice sera were collected 1 week after the last immunization. The serum antibody titers were detected by inhibition ELISA, and the immunogenicities of PS4-DT bulks prepared by different methods were compared. Results The main quality indexes of both PS4-DT bulks met relevant requirement standards, and the conjugated PS4 contents in PS4-DT bulks were 257.1 and 203.0 μg/ml, respectively. Both PS4-DT bulks specifically reacted with PS4 anti-sera. The inhibition ELISA showed that the inhibition rates of both PS4-DT bulks for PS4 anti-sera reached 100%. The anti-PS4 levels induced by mice immunized with 2 PS4-DT bulks were similar, and antibody geometric mean titers were 970.06 and 844.49, respectively. Conclusion The immunogenicities of PS4-DT bulks prepared by the different methods are similar in mice, and both can induce high antibody levels in immunized mice. |
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Keywords: | Streptococcus pneumoniae Polysaccharides bacterial Diphtheria toxoid Vaccines conjugate |
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