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目的观察F基因型腮腺炎减毒活疫苗的急性毒性及长期毒性试验效果。方法取前期制备的F基因型腮腺炎减毒活疫苗进行大鼠急性毒性试验,之后进行临床症状监测及大体病理学检查;并采用恒河猴进行长期毒性试验,之后观察试验动物的临床症状,进行血液学、生化检测、CD4+、CD8+细胞比例检测、病毒血症检测、病毒在组织器官的分布检测以及病理检查。结果急性毒性试验表明给予大鼠相当于人用剂量的1200倍剂量时,无论是临床症状监测还是大体病理学检查,均无明显异常;而长期毒性试验结果表明,恒河猴3次免疫8倍人用剂量时,疫苗对动物临床症状、血液学和血清生化指标无明显影响,CD4+、CD8+细胞比值亦无明显改变,动物的血液及组织器官中均未检出腮腺炎病毒RNA,各组织器官未见明显大体病理学改变。结论 F基因型腮腺炎减毒活疫苗的急性毒性试验及长期毒性试验均无明显异常,充分验证了疫苗的安全性,从而为疫苗进入临床试验提供了数据支持并奠定了基础。
Objective To observe the acute toxicity and long-term toxicity of attenuated live attenuated genotype mumps vaccine. Methods Acute toxicity test of live attenuated FM genotype mumps vaccine was carried out in rats. The clinical symptoms and pathological examination were performed. The long-term toxicity test was performed on rhesus monkeys. The clinical symptoms, Hematology, biochemical tests, CD4 +, CD8 + cell ratio test, viremia test, the virus in the distribution of tissue and organ detection and pathological examination. Results Acute toxicity test showed that no significant abnormalities were observed in both clinical symptoms and gross pathology when administered to rats at a dose equivalent to 1200 times the human dose. Long-term toxicity tests showed that rhesus monkeys immunized 8 times At the dose of human, the vaccine did not affect clinical symptoms, hematology and serum biochemical indexes of animals, and the ratio of CD4 + and CD8 + cells did not change significantly. No mumps virus RNA was detected in the blood and tissues and organs of the animals. No significant gross pathological changes were observed. Conclusion The acute toxicity test and long-term toxicity test of attenuated live attenuated genotype mumps vaccine showed no obvious abnormalities, which fully verified the safety of the vaccine and provided the data support and laid a foundation for the vaccine to enter clinical trials.