摘要
目的:考察大肠杆菌O157:H7多糖蛋白结合疫苗(简称O157疫苗)对大鼠重复肌肉注射的长期毒性,为临床试验提供安全性依据。方法:48只SD大鼠随机分为疫苗组和对照组(均n=24),疫苗组每只每次给予O157疫苗0.5mL(含多糖25μg),对照组给予等体积磷酸盐缓冲溶液,均间隔2周免疫1次,共3次。第1次免疫后2周、第3次免疫后1、3、5周每组每次处死大鼠6只,进行血液学指标、血液生化学指标、组织器官病理、血清特异性抗体、骨髓组织、给药部位组织等的观察和检测。结果:与对照组比较,疫苗组各指标检查未出现有病理意义的改变,部分血液学指标因免疫诱导所致出现动态规律变化,但未见免疫系统损伤。结论:大鼠重复肌肉注射O157疫苗后未发现明显长期毒性和局部刺激性。
OBJECTIVE： To investigate the long - term toxicity of repeated intramuscular injection of Escherichia coli O157 ： H7 polysaceharide -conjugated vaccine（O157） in rats so as to provide safety evidence for clinical trials. METHODS： A total of 48 SD rats were randomly assigned to receive either 0.5 mL vaccine（containing 25 μg polysaccharides） （immunization group, n = 24） or phosphate buffered solution （PBS,control group, n = 24） with the same volume for 3 times at a dose interval of two weeks. Sacrifice of 6 rats in each group were scheduled at 2 weeks after first immunization, and at 1, 3, and 5 weeks after the third immunization, respectively for observation and determination of hematological and biochemical parameters, histopathology, specific antibody, myeloid tissue, the tissues in injection sites, etc. RESULTS： Compared with control group, immunization group showed no significant pathological change except the dynamic regular change of some hematological parameters induced by the immunization, and no immunologic system damage was observed. CONCLUSION： Repeated intra- muscular injection with O157 vaccine in rats wouldn＇t cause overt toxicity and local irritation.
出处
《中国药房》
CAS
CSCD
北大核心
2009年第31期2410-2413,共4页
China Pharmacy
基金
国家863计划引导项目课题(2003AA001049)
关键词
大肠杆菌O157:H7多糖蛋白结合疫苗
长期毒性
大鼠
肌肉注射
Escherichia coli O157 ： H7 polysaccharide-conjugated vaccine
Long term toxicity
Rats
Intramuscular injection
