Ma Yan, Qin Min, Hu Hui-Qiong, Ji Guang, Feng Ling, Gao Na, Gu Jie, Xie Bing-Feng, He Ji-Hong, Sun Ming-Bo
Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Yunnan Key Laboraory of Vaccine Research & Development on Severe Infectious Diseases, Kunming 650118, China.
Zhonghua Shi Yan He Lin Chuang Bing Du Xue Za Zhi. 2011 Jun;25(3):197-200.
In order to search the preparation process and optimazing dosage ratio of adsorbed diphtheria-tetanus-acellular pertussis and sabin inactivated poliovirus combined vaccine (DTaP-sIPV), the neutralizing antibody titers of IPV induced by different concentration of DTaP-sIPV were investigated on rats.
Two batches of DTaP-sLPV were produced using different concentration of sIPV and the quality control was carried. Together with sabin-IPV and DTaP-wIPV ( boostrix-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.
Two batches of prepared DTaP-sIPV and control sLPV 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.
The prepared DTaP-sIPV was safe, stable and effective and could induced high level neutralizing antibody against poliovirus on rats.
为探索吸附无细胞百白破与脊髓灰质炎灭活疫苗(DTaP-sIPV)的制备工艺及优化配比,在大鼠上研究不同浓度的DTaP-sIPV诱导的脊髓灰质炎病毒中和抗体效价。
采用不同浓度的脊髓灰质炎灭活疫苗(sIPV)制备两批DTaP-sIPV并进行质量控制。将DTaP-sIPV与脊髓灰质炎减毒活疫苗(sabin-IPV)和吸附无细胞百白破与全细胞脊髓灰质炎联合疫苗(DTaP-wIPV,比利时葛兰素史克公司生产的百白破-脊髓灰质炎疫苗)作为对照组,于0、1、2月龄按三剂程序对大鼠进行接种。每次接种后30天采集血清样本,采用微量中和试验检测针对三种脊髓灰质炎病毒的中和抗体效价。
制备的两批DTaP-sIPV及对照sIPV均符合《中国药典》(2005年版三部)要求,稳定性良好。所有组中脊髓灰质炎灭活疫苗抗原的血清阳转率均为100%。针对三种脊髓灰质炎病毒的中和抗体几何平均滴度(GMT)均升高。
制备的DTaP-sIPV安全、稳定、有效,能在大鼠上诱导出高水平的针对脊髓灰质炎病毒的中和抗体。