大鼠肌注伤寒Vi多糖蛋白结合疫苗的长期毒性

Long-term toxicity of intramuscularly injected typhoid conjugate vaccine in rats

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.