13价肺炎链球菌多糖结合疫苗的制备及免疫原性研究  

Studies on preparation and immunogenicity of 13-valent pneumococcal polysaccharide conjugate vaccines

作　　者：张明华[1] 石继春[2] 曹欣[1] 任涛[1] 唐秀丽[1] 韩菲[1] 王婷婷[1] 胡鹏[1] 张美香[1] 郝倩[1] 何佳琦[1] 魏文进[1] 郑海发[1] 

机构地区：[1]北京民海生物科技有限公司研发部,102600 [2]中国食品药品检定研究院菌种室,北京100050

出　　处：《国际生物制品学杂志》2013年第3期118-122,共5页International Journal of Biologicals

基　　金：国家高科技研究发展计划（2012AA02A403）

摘　　要：目的制备13价肺炎链球菌多糖结合疫苗，并初步研究其免疫原性。方法将通过偶联方法制成的13种单价肺炎链球菌多糖结合疫苗，配制成含或不含铝佐剂的13价肺炎链球菌多糖结合疫苗。用制备的2种疫苗分别免疫猕猴和家兔，以ELISA法检测免疫动物的血清抗多糖抗体水平。结果制备的2种疫苗的各项指标均达到质控标准。末次免疫后，含或不含铝佐剂疫苗免疫猕猴的平均血清抗各型多糖抗体阳转率分别为98．08％和94．23％；含或不含铝佐剂疫苗免疫家兔的平均血清抗各型多糖抗体阳转率分别为95．38％和96．92％。结论成功研制了13价肺炎链球菌多糖结合疫苗，含或不含铝佐剂疫苗在猕猴和家兔中均具有免疫原性。Objective To prepare 1S-valent pneumococcal polysaccharide conjugate vaccines and study their immunogenicity preliminarily. Methods 13 monovalent pneumococcal polysaccharide conjugate vaccines were prepared by coupling method. 13-valent pneumococcal polysaccharide conjugate vaccines with or without aluminium adjuvant were prepared by mixing 13 monovalent pneumococcal polysaccharide conjugate vaccines. Macaques and rabbits were immunized with both kinds of prepared vaccines, and levels of serum antibodies to polysaccharide were detected by ELISA. Results All the indexes of two kinds of prepared vaccines met the standard of quality control. After the last immunization, average seroconversion rates in macaques immunized with 1S-valent pneumococcal polysaccharide conjugate vaccine with or without aluminium adjuvant were 98.08% and 94.23% , respectively; average seroconversion rates in rabbits immunized with 13- valent pneumococcal polysaccharide conjugate vaccine with or without aluminium adjuvant were 95.38% and 96. 92%, respectively. Conclusions 13-valent pneumococcal polysaccharide conjugate vaccines are successfully prepared. No matter whether the vaccines contain adjuvant or not, they have immunogenicity in macaques and rabbits.

关 键 词：链球菌 肺炎 疫苗 结合 免疫原性 

分 类 号：R392[医药卫生—免疫学]