日本血吸虫双价DNA疫苗对小鼠单次肌肉注射的毒性试验

Acute toxicity test of Schistosoma japonicum bivalent DNA vaccine with single dosage in mice

目的观察日本血吸虫双价DNA疫苗单次肌肉注射小鼠的急性中毒反应,初步评价其安全性。方法40只BALB/c小鼠(雌雄各半)随机分为4组,即10、20mg/kg给药组,空白质粒和生理盐水对照组,连续观察14d。结果各组动物无死亡,疫苗10mg/kg组未见明显毒性反应,疫苗20mg/kg组有个别动物出现短暂的活动减少,而空白质粒对照组出现活动减少和体重下降。结论日本血吸虫双价DNA疫苗对小鼠单次肌肉注射给药无明显毒性反应,预期临床应用安全性好。

Objective To investigate the acute toxicity of Schistosoma japonicum bivalent DNA vaccine. Methods Forty male and female BALB/c mice were randomly divided into 4 groups. The mice of low dose group were given each once only by iniection of muscle 10 mg/kg, ones of high dose group were given each in the same way with 20 mg/kg, and two control groups given each equivalent volume of 100 μl 0.9% NaCl and 100 μg pVIVO2. The investigation of 4 groups lasted 14 d. Indexes of hematology, weights coefficients of organs etc. were subjected to systematic examinations. Results There was no animal dead and there were no significant changes（P〉0.05） in hematology,weights coefficients of organs and pathological changes in all organs. Conclusions There are no abnormal changes in the acute toxicity trial with Schistosoma japonicum bivalent DNA vaccine, and bivalent DNA vaccine could be safe in clinical trial.