摘要
目的 探讨吸附无细胞百白破-Sabin株脊髓灰质炎联合疫苗（DTaP-sIPV）的制备工艺,并比较不同配比的DTaP-sIPV中Sabin株脊髓灰质炎灭活疫苗（SabinIPV）三针基础免疫大鼠的中和抗体效价,为确定联合疫苗的最佳制备工艺及抗原剂量配比提供参考.方法 用不同配比的SabinIPV,制备两批DTaP-sIPV,进行各项指标的检定及稳定性试验,并联合单独的Sabin IPV和GSK制备的DTaP-wIPV对56只Wistar大鼠进行3针免疫,每针间隔1个月,每次免疫后30 d采血并分离血清,采用微量中和试验测定血清中抗脊髓灰质炎病毒3个型别的中和抗体效价.结果 两批DTaPsIPV的各项检定指标均符合〈中国药典〉三部（2005版）要求,且稳定性良好.大鼠经3针基础免疫后,其Ⅰ、Ⅱ、Ⅲ型脊髓灰质炎病毒中和抗体的几何平均滴度均显著上升,3针免疫后抗体阳转率已经达到100%.结论 经此制备的DTaP-sIPV安全、稳定、有效,且DTaP-sIPV中的SabinIPV在大鼠中有良好的免疫效果,经3针免疫可产生高水平的中和抗体.
Objective In order to search the preparation process and optimazing dosage ratio of adsorbed diphtheria-tetanus-acellular pertussis and sabin inactivated poliovirus combined vaccine （ DTaPsIPV） , the neutralizing antibody titers of IPV induced by different concentration of DTaP-sIPV were investigated on rats. Methods Two batches of DTaP-sIPV were produced using different concentration of sIPV and the quality control was carried. Together with sabin-IPV and DTaP-wIPV （ boostriixTM-polio, GSK, Belgium） as control group,the DTaP-sIPV were administrated on three-dose schedule at 0,1,2 month on rats. Serum sample were collected 30 days after each dose and neutralizing antibody titers against three types poliovirus were determined using micro-neutralization test. Results Two batches of prepared DTaP-sIPV and control sIPV were according to the requirement of Chinese Pharmacopoeia （ Volume Ⅲ , 2005 edition） and showed good stability. The seropositivity rates were 100% for sabin inactivated poliovirus antigen in all groups. The GMTs（ Geometric mean titers） of neutralizing antibodies against three types poliovirus increased. Conclusion The prepared DTaP-sIPV was safe, stable and effective and could induced high level neutralizing antibody against poliovirus on rats.
出处
《中华实验和临床病毒学杂志》
CAS
CSCD
北大核心
2011年第3期197-200,共4页
Chinese Journal of Experimental and Clinical Virology
基金
国家＂重大新药创制＂科技重大专项（2008ZX09101031）
云南省科技创新强省计划（2007AD015）
