重组HIV-1腺病毒载体活疫苗的冻干保护剂研究

目的研制重组HIV-1腺病毒载体活疫苗的冻干保护剂。方法在重组HIV-1腺病毒载体活疫苗中加入不同配比的保护剂,在适宜条件下制备成冻干剂型。根据冻干后外观、病毒滴度和热稳定性试验等结果,筛选出冻干保护剂的最适配方。结果以人血白蛋白、海藻糖、甘露醇、右旋糖苷和蔗糖等成分按比例配伍制备的保护剂,对重组HIV-1腺病毒载体活疫苗显示了较好的保护作用。冻干前后疫苗病毒感染性滴度下降在0.17LogCC ID50/ml以内;37℃放置1周,滴度下降0.3LogCC ID50/ml左右;37℃放置3周后,滴度下降约为0.6LogCC ID50/ml。而无保护剂的液体疫苗对照于37℃放置1周,滴度下降近2.5个LogCC ID50/ml。结论以人血白蛋白、海藻糖、甘露醇、右旋糖苷和蔗糖等配伍而制备的保护剂效果较好。

Preparation of Stabilizer of Freeze-dried Adenovirus-based Live HIV Vaccine

Objective To prepare the stabilizer of freeze-dried adenovirus-based live HIV vaccine.Methods Add stabilizers with different formula into adenovirus-based live HIV vaccine and prepare the vaccine into freeze-dried form under appropriate conditions.Screen the optimal stabilizer according to the appearance,virus titer and thermostability of the freeze-dried vaccine.Results The stabilizer containing human serum albumin,trehalose,mannitol,dextran and sucrose showed good protective effect on freeze-dried adenovirus-based live vaccine.Compared with that before lyophilization,the infectious titer of vaccine after lyophilization decreased by not more than 0.17 LogCCID_(50)/ml.The titer of freeze-dried vaccine decreased about 0.3 LogCCID_(50)/ml at 37℃ for one week and not more than 0.6 LogCCID_(50)/ml for 3 weeks.However,the titer of liquid vaccine containing no stabilizer decreased by nearly 2.5 LogCCID_(50)/ml at 37℃ for one week.Conclusion The stabilizer containing human serum albumin,trehalose,mannitol,dextran and sucrose was suitable for freeze-dried adenovirus-based HIV vaccine.