摘要
目的研究25℃与37℃恒温状态下疫苗温度指示标签(vaccine vial monitor,VVM)失效时间与b型流感嗜血杆菌(Haemophilus influenzae type b,Hib)结合疫苗有效性指标之间的关系,判断VVM对疫苗温度暴露情况的指示作用是否可靠。方法将检定合格的3批贴有VVM标签的Hib结合疫苗分别放置于25℃与37℃温度中,25℃放置的样品于0、10、20、30、40、50、60 d取样,37℃放置的样品于3、7、9 d取样,检测VVM反应区与参照区吸光度差值和Hib结合疫苗各有效性质量指标之间的关系。当测量VVM上至少2个点的AR-I≤0.00时,肉眼观察反应区颜色与参照区颜色相同或更深,提示VVM失效。绘制VVM吸光度差值结果与疫苗有效性变化统计表和曲线图,研究VVM与疫苗失效时间的先后顺序,了解VVM是否存在先于疫苗失效的情况。结果25℃时,VVM开始失效的时间范围为45~50 d;37℃下,VVM开始失效的时间范围为6~7 d。疫苗在25℃放置60 d和37℃放置7 d,各有效性指标均符合标准规定。观察期内未发现疫苗失效情况,疫苗稳定性较好。结论2种温度下VVM均于疫苗失效前到达终点。证明VVM应用于Hib结合疫苗的匹配性良好,可反映该疫苗的热暴露情况,为疫苗接种前的有效性确认提供可靠帮助。
Objective To investigate the relationship of the failure time between vaccine vial monitor(VVM)and the potency related attributes of Haemophilus influenzae type b(Hib)conjugate vaccine at 25℃and 37℃respectively,so as to determine whether the indicator effect of VVM on vaccine exposured temperature was reliable.Methods Total of 3 batches of detected qualified Hib conjugate vaccines with VVM labelling were placed at 25℃and 37℃,respectively.Samples at 25℃on 0,10,20,30,40,50,60 d,and samples at 37℃on 3,7,9 d,were separately sampled.The difference of absorbance values from VVM reaction area and indicator area were detected to compare the potency related attributes of Hib vaccine.It indicated a VVM failure,by a naked eye observation,that the absorbance with different values at least two points on VVM was AR-I≤0.00,the color of indicator area had the same degree or darker than that of the reference zone.In search for the time order from VVM and vaccine failure,and understand whether VVM failed before vaccine failure,the VVM absorbance difference,the statistical table and graph of the change of vaccine effectiveness were combined.Results The time range of VVM failure was 45-50 d,at 25℃,and the time range of VVM failure was 6-7 d,at 37℃.The vaccines were placed at 25℃for 60 days and 37℃for 7 days,and the potency related attributes still met the specifications.No vaccine failure was found during the observation period,and the vaccine stability was in a normal state.Conclusion It was before vaccine failure at both temperature conditions that VVM reached the end point,on which VVM was proved a good monitor for Hib conjugate vaccine,could reflect the heat exposure on the vaccine and provide a reliable information for the validation of effectiveness beforehand vaccination.
作者
高晶晶
冯琪蓉
马平
田盛举
安建科
董继刚
刘东梅
杜送田
刘晨鸣
刘晓凡
GAO Jing-jing;FENG Qi-rong;MA Ping;TIAN Sheng-ju;AN Jian-ke;DONG Ji-gang;LIU Dong-mei;DU Song-tian;LIU Chen-ming;LIU Xiao-fan(Quality Assurance Department,Lanzhou Institute of Biological Products Co.,Ltd.,Center for Gansu Provincial Vaccine Engineering Research,Lanzhou 730046,Gansu Province,China)
出处
《微生物学免疫学进展》
2020年第4期41-46,共6页
Progress In Microbiology and Immunology
