【摘要】 目的 比较经基因工程方法脱毒的无细胞百日咳疫苗(APV)中不同含量活性PT的保护作用。方法 用小鼠保护性试验(AMPT)评价不同含量活性PT疫苗样品的百日咳效力,组织胺致敏试验(HST)检测不同含量PT样品中PT活性。结果 含5ng活性PT的疫苗与不含PT的疫苗效力差异无显著意义;含50ng活性PT疫苗与不含和含5ng活性PT的疫苗效力差异有显著意义。用HST肛温测定法可以检测到含50ng活性PT的样品中PT活性。结论 AMPT适用于高度脱毒或基因工程脱毒的APV的效力检定,HST肛温测定法可以证实APV中PT的活性。更多还原

【Abstract】 Objective To compare the protection roles of active pertussis toxin (PT) at different concentrations of genetically detoxified acellular pertussis vaccine ( APV) .Methods Evaluate the potency of APV containing different concentrations of active PT by modified active mouse protection test (AMPT) and determine the PT activity in the vaccine by histamine sensitization test(HST). Results No significant difference was observed between the potencies of APV containing 5ng and no active PT. However, the potency of APV containing 50 ng active PT was significantly different from those containing no and 5 ng active PT. The PT activity in the APV containing 50 ng active PT could be detected by HST. Conclusion AMPT is suitable for the potency test of highly detoxified or genetically detoxified APVs, and the PT activity in APV can be detected by HST.更多还原