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大鼠肌注甲型副伤寒多糖蛋白结合疫苗的长期毒性
Long-term toxicity of intramuscularly injected paratyphoid A polysaccharide protein binding vaccine in rats
【摘要】 目的:观察SD大鼠肌注甲型副伤寒多糖蛋白结合疫苗的长期毒性。方法:对照组大鼠(n=24)免疫3剂,每次每只肌注生理氯化钠溶液-甘氨酸溶液0.5mL,疫苗组大鼠(n=24)免疫3剂,每次每只25μg(以多糖量计)。第1剂免疫后2周、第3剂免疫后1,3和5周各处死6只大鼠,测血常规、血清测特异性抗体、血清生化,并进行组织器官病检。结果:疫苗组大鼠血液学白细胞分类出现可逆性的变化(P<0.05),但无明显毒性,血清特异性抗体阳性大鼠病理组织检查未见免疫毒理学损伤。疫苗组大鼠的血液学和血清生化指标等与对照组比较未见显著性差异。结论:甲型副伤寒结合疫苗对大鼠有明显的免疫原性,但无明显毒性和局部刺激性。
【Abstract】 Objective:To evaluate the long-term toxicity of intramuscularly injected paratyphoid A polysaccharide protein binding vaccine in SD rats.Methods: Rats(n=24) were immunized by intramuscular injection of paratyphoid A polysaccharide protein binding vaccine at 25 μg per rat for 3 times.Saline-glycine solution 0.5 mL was injected as control(n=24).At 2 weeks after the first immunization,and 1,3 and 5 weeks after the third immunization,6 rats were respectively sacrificed for examination of hematology,serum biochemistry,the specific antibody against vaccine,and histopathology.Results: In rats immunized with the vaccine,reversible changes of hematology were observed,but did not show apparent toxicity.Immunotoxic damage was not found by histopathology examination in specific antibody-positive rats,suggesting that the specific antibody would not be harmful to the rats.There were no significant differences in the indices of haematology and biochemistry between vaccine group and control group.Conclusion: Paratyphoid A polysaccharide protein binding vaccine has potent immunogenicity,but no detectable toxicity after repeated immunization in rats.
【Key words】 paratyphoid A polysaccharide protein binding vaccine; long-term toxicity; immunogenicity; immunotoxicity;
- 【文献出处】 中国新药杂志 ,Chinese Journal of New Drugs , 编辑部邮箱 ,2009年19期
- 【分类号】R96
- 【下载频次】95