单纯疱疹病毒Ⅰ型糖蛋白B核酸疫苗安全性的初步评价

Initial evaluation on safety of herpes simplex virus Ⅰglycoprotein B DNA vaccine in mice

目的:通过检测免疫小鼠的血液生理学、血液生化学指标,以及8个重要组织器官的病理学,初步评估单纯疱疹病毒Ⅰ型糖蛋白B核酸疫苗(pcDNA3-gB)的安全性。方法:将24只昆明种小鼠随机分为对照组、100、300和500mg.L-1组,每组6只。各组分别于小鼠股四头肌肌肉注射1mL生理盐水、100、300和500mg.L-1pcDNA3-gB。末次免疫10d后,进行血液生理学、血液生化学、肝、肾、心、脑、脾、角膜、视网膜、三叉神经节的病理学检查。结果:各组小鼠均存活,且血红细胞计数(RBC)、血红蛋白浓度(HB)、红细胞压积(HCT)、红细胞平均体积(MCV)、红细胞平均血红蛋白(MCH)、红细胞平均血红蛋白浓度(MCHC)、血小板记数(PLT)、白细胞计数(WBC)、红细胞体积分布宽度(RDW)、谷丙转氨酶(ALT)、谷草转氨酶(AST)、碱性磷酯酶(ALP)、总胆红素(T-BIL)、尿素(BUN)、肌肝(Cr)、总蛋白(TP)、白蛋白(ALB)、血糖(GLU)及组织病理学与对照组比较差异均无显著性(P>0.05)。结论:不同剂量pcDNA3-gB免疫小鼠后,对小鼠的生命、血液生理学、血液生化学、组织病理学指标均无明显影响,初步说明pcDNA3-gB是安全的。

Objective To evaluate the safety of herpes simplex virus Ⅰ glycoprotein B DNA vaccine （pcDNA3-gB） in mice by examing the indexes of hematology, hematological biochemistry and pathological results of eight important organs of immunized mice. Methods Twenty-four mice were divided into four groups （n=6） randomly, including control group, 100, 300 and 500 mg·L^-1 pcDNA3 gB groups, and 1 mL sodium chloride, 100, 300 and 500 mg·L^-1 pcDNA3-gB were injected into mice through the quadriceps in various groups. At the 10th day after last immunity, the blood samples were collected and the indexes of hematology, hematology biochemistry and the pathological results of liver, kidney, heart, brain, spleen, cornea, retina and trigeminal ganglia were examined. Results The differencesinRBC, HB, HCT, MCV, MCH, MCHC, PLT, RDW, WBC, ALT, AST, ALP, T-BIL, GLU, ALB, TP, Cr, BUN betwen control group and pcDNA3-gB groups were not significant as well as the pathological results of liver, heart, kidney, brain, spleen, cornea, retina and trigeminal ganglion （P〉0.05）. Conclusion pcDNA3-gB with different doses have not significant effect on the indexes of hematology,hematological biochemistry and pathology in immunized mice. It is initially proved that pcDNA3-gB is safe.