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目的观察北京株(VZV84-7)水痘病毒在麻疹-腮腺炎-风疹-水痘(measles-mumps-rubella-varicella,MMRV)联合减毒活疫苗中的稳定性。方法将4批MMRV联合减毒活疫苗成品分别置37℃保存4周、2~8及-15~-20℃保存24个月,采用蚀斑形成单位(plaque forming unit,PFU)试验检测不同时间点疫苗中水痘病毒滴度。将水痘病毒原液于-80℃反复冻融1、2、3次后,分别与麻疹、腮腺炎、风疹各单价疫苗原液按一定比例配制成MMRV联合减毒活疫苗,进行冻干,采用PFU试验分别测定冻干前、冻干后基础水痘病毒滴度及冻干后于37℃热稳定1周的水痘病毒滴度。结果 4批MMRV联合减毒活疫苗成品于37℃保存4周后,水痘病毒滴度下降范围为0.5~0.7 lg PFU/ml;于2~8℃保存24个月,水痘病毒滴定最高达4.6 lg PFU/ml,最低为4.4 lg PFU/ml;于-15~-20℃放置24个月,水痘病毒滴度基本保持不变,均达合格标准(不低于3.6 lg PFU/ml)。水痘病毒原液经1、2、3次冻融后制备的MMRV,通过37℃热稳定1周,水痘病毒滴度分别为4.9~4.6、4.6~4.4、4.5~4.3 lg PFU/ml,均达到合格标准(不低于3.6 lg PFU/ml)。结论北京株(VZV84-7)水痘病毒在MMRV联合减毒活疫苗中稳定性良好。
Objective To investigate the stability of varicella virus (VZV84-7) in combination with live attenuated measles-mumps-rubella-varicella (MMRV) vaccine. Methods Four batches of MMRV live attenuated vaccine were stored at 37 ℃ for 4 weeks, stored at 2 ~ 8 and -15 ~ -20 ℃ for 24 months respectively. The plaque forming unit (PFU) Point vaccine varicella virus titer. The varicella virus solution was repeatedly frozen and thawed at -80 ℃ for 1, 2 and 3 times. Multivariate vaccine combinations of measles, mumps and rubella were respectively formulated into MMRV attenuated live attenuated vaccine and PFU test The varicella virus titers were determined before and after lyophilization, respectively, and were stable for 1 week at 37 ° C after lyophilization. Results After four batches of MMRV live attenuated vaccine were stored at 37 ℃ for 4 weeks, the varicella titers dropped from 0.5 to 0.7 lg PFU / ml. After 2 to 8 ℃ for 24 months, varicella virus titer reached 4.6 lg PFU / ml, the lowest was 4.4 lg PFU / ml. After being stored at -15 ~ -20 ℃ for 24 months, the varicella virus titer remained basically unchanged (no less than 3.6 lg PFU / ml). The MTCV of the varicella virus solution was thawed at 1, 2, 3 times. After being heat-stable at 37 ℃ for 1 week, the varicella virus titers were 4.9 ~ 4.6, 4.6 ~ 4.4 and 4.5 ~ 4.3 lg PFU / ml respectively, Standard (not less than 3.6 lg PFU / ml). Conclusion The VZV84-7 varicella virus has good stability in live attenuated MMRV vaccine.