Long-term Toxicity of Repeated Intramuscular Injection of Escherichia Coli O157:H7 Polysaccharide-conjugated Vaccine in Rats
- VernacularTitle:大肠杆菌O157:H7多糖蛋白结合疫苗重复肌肉注射对大鼠的长期毒性研究
- Author:
Wudang LU
;
Zhicheng LI
;
Mingtang GAO
;
Yongjie WU
;
Wenguang LI
- Publication Type:Journal Article
- Keywords:
Escherichia coli O157∶H7 polysaccharide-conjugated vaccine;
Long-term toxicity;
Rats;
Intramuscular injection
- From:
China Pharmacy
2007;0(31):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To investigate the long-term toxicity of repeated intramuscular injection of Escherichia coli O157∶H7 polysaccharide-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 ?g 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 intramuscular injection with O157 vaccine in rats wouldn't cause overt toxicity and local irritation.
