Immunogenicity and technological stability of conjugate vaccine prepared by activation of group A meningococcal polysaccharide with 1-cyano-4-dimethylaminopyridinium tetrafluoroborate
目的分析1-氰基-4-二甲基氨基吡啶·四氟化硼(1-cyano-4-dimethylaminopyridinium tetrafluoroborate,CDAP)活化A群脑膜炎球菌多糖(group A meningococcal polysaccharide,Men APS)制备的A群脑膜炎球菌结合疫苗的免疫原性及其工艺稳定性。方法用CDAP活化多糖后,己二酰肼(adipic dihydrazide,ADH)衍化,制备多糖-酰肼基衍生物,在碳二亚胺[1-ethyl-3-(3-dimethylaminopmpyl)carbodiimide,EDAC]作用下,与TT偶联,制备A群脑膜炎球菌多糖结合疫苗原液(Men APSCDAP-TT),考察其免疫特性;将Men A PSCDAP-TT与C群脑膜炎球菌多糖结合疫苗原液混合,制备A、C群脑膜炎球菌结合疫苗(Men ACPSCDAP-TT),再与市售的采用溴化氰(CNBr)活化多糖制备的A、C群脑膜炎球菌结合疫苗(Men ACPSCNBr-TT)进行抗A群多糖Ig G抗体水平的比较。连续制备12批结合疫苗原液及9批结合疫苗,原液参考《中国药典》三部(2010版)进行各...
【英文摘要】
Objective To analyze the immunogenicity and technological stability of conjugate vaccine prepared by activation of group A meningococcal polysaccharide(Men APS) with 1-cyano-4-dimethylaminopyridinium tetrafluoroborate(CDAP). Methods Men APS was activated with CDAP and derived with adipic dihydrazide(ADH),then coupled to TT with 1-ethyl-3-(3-dimethylaminopmpyl) carbodiimide(EDAC) to prepare the bulk of Men APSCDAP-TT and evaluate its immunological characters. The bulk of Men APSCDAP-TT was mixed with that of...
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