我国黄热减毒活疫苗的稳定性研究

Study on stability of live attenuated yellow fever vaccine in China

目的通过测定我国黄热减毒活疫苗在不同储存条件、不同储存时间的病毒滴度,为该疫苗的稳定性研究提供数据支持。方法测定存放于-20℃、4℃、25℃、37℃不同时间点的黄热减毒活疫苗的病毒滴度;测定过期不同时间点的疫苗的病毒滴度;测定疫苗运输时脱冷链后又正常储存在-20℃的疫苗的病毒滴度;测定疫苗复溶后不同时间点的病毒滴度。结果储存在-20℃24个月(有效期)的黄热减毒活疫苗,病毒滴度仅下降0.4~0.5 LgPFU/ml;疫苗于4℃、25℃、37℃放置8周,病毒滴度分别下降0.7 LgPFU/ml、1.0~1.4 LgPFU/ml、2.3~2.6 LgPFU/ml;疫苗超过有效期8个月、10个月、44个月、76个月,病毒滴度下降分别为0.4~0.6 LgPFU/ml、0.6~0.7 LgPFU/ml、0.6~0.7 LgPFU/ml、0.9 LgPFU/ml;疫苗放置4℃2 h、25℃2 h、37℃2 h及-20℃存放2周后,病毒滴度仅有0~0.2 LgPFU/ml的轻微下降;疫苗复溶后,室温存放120 min,滴度仅下降0.1~0.4 LgPFU/ml。结论我国黄热减毒活疫苗稳定性良好,在现行标准的储存温度-20℃下非常稳定。无论是冻干状态还是复溶后,短时间的高温暴露对疫苗的病毒滴度影响不大。

Objective To study the viral titers of live attenuated yellow fever vaccine in China under different storage conditions and time,and to provide data to support the stability of the vaccine.Methods The viral titers of live attenuated yellow fever vaccines stored at different time points at-20℃,4℃,25℃and 37℃were determined;the viral titers of vaccines stored at different time points at the viral titers of vaccines expired for different time points were determined;the viral titers of vaccines were determined after storing at-20℃after being taken away from the cold-chain during transportation;the titer of the virus was determined at different time points after thawing.Results The viral titer of the live attenuated yellow fever vaccine stored at-20℃for 24 months(validity period)decreased only by 0.4-0.5 LgPFU/ml;the viral titer decreased by 0.7 LgPFU/ml,1.0-1.4 LgPFU/ml and 2.3-2.6 LgPFU/ml respectively when the vaccine was stored at 4℃,25℃and 37℃for 8weeks.The viral titers decreased by 0.4-0.6 LgPFU/ml,0.6-0.7 LgPFU/ml,0.6-0.7 LgPFU/ml and 0.9 LgPFU/ml respectively 8 months 10 months,44 months and 76 months after the expiration date.The titer of the virus decreased slightly from 0 to 0.2 LgPFU/ml when the vaccine was stored at 4℃for 2 h,25℃for 2 h,37℃for 2 h,then-20℃for 2 weeks.Afterthawing,the titers of virus decreased by 0.1-0.4 LgPFU/ml at room temperature for 120 minutes.Conclusions The live attenuated yellow fever vaccine in China has good stability and is very stable at the current standard storage temperature-20℃.Short time exposure to high temperature,whether in lyophilized state or after being thawed,the viral titer of vaccine remained almost unchanged.