重组MVA病毒载体疫苗的冻干保护剂研究

目的研制重组MVA病毒载体疫苗的耐热冻干保护剂。方法在重组MVA病毒载体疫苗中加入不同配比的保护剂,在适宜的条件下制备成冻干剂型。根据冻后外观、病毒滴度和热稳定性等结果,筛选出保护剂的最适配方。结果以海藻糖、甘露醇、右旋糖苷和肌醇等按比例、配伍而成的保护剂,对MVA病毒载体疫苗显示了较好的保护性,疫苗冻干前后病毒滴度下降在0.12LgPFU/ml以内,37℃放置1周,滴度下降0.35LgPFU/ml左右;放置3周,滴度下降不超过1LgPFU/ml。而无保护剂的液体疫苗对照于37℃放置1周,滴度下降近1LgPFU/ml;放置3周,滴度下降3.5LgPFU/ml左右。结论以海藻糖、甘露醇、右旋糖苷和肌醇等配伍而成的保护剂是一种良好的疫苗保护剂。

Preparation of Stabilizer of Freeze-dried Recombinant MVA Virus Vector Vaccine

Objective To prepare the stabilizer of freeze-dried recombinant MVA virus vector vaccine.Methods Add the stabilizers prepared with various formula into recombinant MVA virus vector vaccine,then lyophilize the vaccine under appropriate condition.Screen the optimal formula of stabilizer according to the appearance,virus titer and thermostability of the freeze-dried vaccine.Results The stabilizer prepared with trehalose,mannitol,dextran and inositol showed good protective effect on recombinant MVA virus vector vaccine.The decrease of virus titer after lyophilization was less than 0.12 LgPFU/ml,and those after storage at 37℃ for 1 and 3 weeks were about 0.35 LgPFU/ml and not more than 1 LgPFU/ml respectively.However,the virus titers of stabilizer-free liquid vaccine decreased by 1 LgPFU/ml and 3.5 LgPFU/ml under the same condition respectively.Conclusion The stabilizer consisting of trehalose,mannitol,dextran and inositol provided good protective effect for the freeze-dried recombinant MVA virus vector vaccine.