【摘要】 目的按初步确定的工艺,制备A群奈瑟脑膜炎球菌荚膜多糖(Group A Neisseria meningococcus capsular polysac charide,GAMP)与破伤风类毒素(Tetanus toxoid,TT)的结合物,通过监测关键工艺参数,分析该工艺的稳定性。方法制备8批GAMP-TT结合物,经Sepharose4FF柱层析纯化后,进行各项生化鉴定,采用双向免疫扩散试验检测其抗原性,以结合物皮下免疫小鼠,ELISA检测小鼠血清中抗GAMP及抗TT IgG抗体水平。结果制备的8批结合物工艺关键参数较稳定,均保持GAMP抗原特异性;免疫小鼠后,均可诱生较高水平的血清抗GAMP IgG抗体,并可诱生免疫加强应答。结论该制备工艺稳定,为GAMP-TT结合疫苗的研制提供了参考。更多还原

【Abstract】 Objective To prepare group A Neisseria meningococcus capsular polysaccharide(GAMP)-tetanus toxoid(TT) conjugate by a preliminarily developed procedure,and analyze the stability of the procedure by monitoring the key technological parameters.Methods Eight batches of GAMP-TT conjugate were prepared,then purified by Sepharose 4FF column chromatography,subjected to biochemical assay,and determined for antigenicity by double immunodiffusion test.Mice were immunized s.c.with the conjugate and determined for IgG levels against GAMP and TT in sera by ELISA.Results The key technological parameters during preparation of the eight batches of conjugate were stable.All the eight batches of conjugate showed antigenic specificity,induced high IgG titers against GAMP and TT in sera and induced booster response of mice.Conclusions The procedure was stable,which provided a reference for the preparation of GAMP-TT conjugate vaccine.更多还原