摘要目的:研究乙型脑炎减毒活疫苗在动物皮下接种后的毒性反应和全身主动过敏反应，考察疫苗安全性。方法:采用Sprague-Dawley大鼠皮下注射单次给药毒性试验评价疫苗的急性毒性；采用豚鼠全身主动过敏试验评价疫苗的致敏性。结果:乙型脑炎减毒活疫苗以1.50 mL/只的剂量单次皮下注射给予大鼠，未见与供试品相关的毒性反应，最大耐受量为1.50 mL/只。乙型脑炎减毒活疫苗分别以0.05 mL/只（低剂量）和0.50 mL/只（高剂量）皮下注射致敏3次，并在末次致敏后14 d以0.10 mL/只（低剂量）和1.00 mL/只（高剂量）静脉注射激发，可导致豚鼠发生全身主动过敏反应。结论:乙型脑炎减毒活疫苗在动物皮下接种后，毒性反应和全身主动过敏反应符合动物安全性评价要求。

abstractsObjective:To study toxic reactions and active systemic allergic reactions to live attenuated Japanese encephalitis vaccine (JEV) in animals after subcutaneous vaccination to examine vaccine safety.Methods:The acute toxicity of JEV was evaluated by subcutaneous injection single administration toxicity test in Sprague-Dawley（SD）rats, and the sensitization of JEV was evaluated by active systemic anaphylaxis in guinea pigs.Results:JEV was administered subcutaneously to SD rats at a dose of 1.50 mL per animal, and no toxic reactions related to the test substance were observed. The maximum tolerable dose was 1.50 mL per animal. JEV was administered subcutaneously 3 times at 0.05 mL/piece（low dosage）and 0.50 mL/piece（high dosage）for sensitization, and intravenously at 0.10 mL/piece（low dosage）and 1.00 mL/piece（high dosage）for stimulation, respectively, 14 days after the last sensitization. Active systemic allergic reactions were observed in guinea pigs.Conclusion:After subcutaneous administration of JEV in animals, the toxic reactions and active systemic allergic reactions meet the requirements of animal safety evaluation.