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作 者:李志成[1] 覃红[1] 吴梦龙[2] 杜琳[3] 谭小梅[3] 高明堂[1] 李文广[1] 吴勇杰[1]
机构地区:[1]兰州大学基础医学院药理学教研室、甘肃省新药临床前研究重点实验室,兰州730000 [2]华中科技大学同济医学院,武汉430030 [3]兰州生物制品研究所,兰州730046
出 处:《中国新药杂志》2008年第7期565-569,共5页Chinese Journal of New Drugs
基 金:863重大课题“疫苗与工程抗体”专项课题(编号:2006AA02A218);甘肃省科技重大专项课题(编号:2GS052-A43-008-01)
摘 要:目的:观察SD大鼠肌注伤寒Vi多糖蛋白结合疫苗的长期毒性。方法:疫苗组大鼠(n=24)免疫3针,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,P<0.01),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。结论:伤寒Vi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。Objective: To evaluate the long-term toxicity of intramuscularly injected typhoid conjugate vaccine in Sprague-Dawley (SD) rats. Methods: Rats (n = 24) were repeatedly immunized with intramuscular typhoid conjugate vaccine at 25 μg for 3 times. Two weeks after the first immunization, 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 examination of histopathology in specific antibody-positive rats, suggesting that the specific antibody would not be harmful to the rats. Conclusions: Typhoid conjugate vaccine after repeated immunization has potent immunogenicity but no observed toxicity in rats.
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