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 13-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 13-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 the adjuvant or not, they have immunogenicity in macaques and rabbits.