麻疹-流行性腮腺炎-流行性乙型脑炎联合减毒活疫苗的安全性评价

发布时间：2018-06-25 19:34

本文选题：麻疹-流行性腮腺炎-流行性乙型脑炎联合减毒活疫苗 + 安全性评价　；参考：《中国疫苗和免疫》2014年06期

【摘要】：目的进行麻疹-流行性腮腺炎(流腮)-流行性乙型脑炎(乙脑)联合减毒活疫苗(Measles,Mumps and Japanese Encephalitis Combined Attenuated Live Vaccine,M-M-JEV)的安全性评价。方法小鼠急性毒性试验:设M-M-JEV拟用临床剂量的80倍为低剂量,拟用临床剂量的400倍为高剂量,1次皮下注射给药,同时设阴性对照。观察临床症状,检查注射部位、体重、病理学。猴体长期毒性试验:设M-M-JEV拟用临床剂量为低剂量,拟用临床剂量的5倍为高剂量,2次皮下注射给药,同时设阴性对照及麻疹减毒活疫苗、流腮减毒活疫苗和乙脑减毒活疫苗对照。观察临床症状,检查注射部位、体温、体重、心电图、血液学、血清生物化学、摄食量、尿液、眼科学以及血清中和抗体(Neutralizing Antibody,NA)的变化情况,大体病理学和组织病理学检查。结果各项观察指标及检查结果均与对照疫苗或阴性对照相似,相关数据与对照疫苗或阴性对照组比较差异无统计学意义,未见其他明显毒副作用,第1次给药后4周,麻疹病毒NA、流腮病毒NA及乙脑病毒NA水平与对照单价疫苗比较差异均无统计学意义。结论M-M-JEV表现出与单价疫苗相似的安全性和免疫原性。
[Abstract]:Objective to evaluate the safety of measles Mumps and Japanese Encephalitis combined Attenuated Live Vaccine M-M-JEV. Methods Acute toxicity test in mice: the clinical dose of M-M-JEV was 80 times as low as that of clinical dose, and the 400 times of clinical dose was high dose once subcutaneously, and the negative control group was set up at the same time. Clinical symptoms were observed, injection site, body weight and pathology were examined. The long-term toxicity test of monkey body: the clinical dose of M-M-JEV was low, the 5 times of clinical dose was high dose, and the negative control and live measles attenuated vaccine were set up. Gills attenuated live vaccine and Japanese encephalitis attenuated live vaccine control. The changes of clinical symptoms, body temperature, body weight, electrocardiogram, hematology, serum biochemistry, intake, urine, ophthalmology and serum neutralizing antibody (Neutralizing Antibody na) were observed. Results the observed indexes and examination results were similar to those of the control vaccine or the negative control group. There was no significant difference in the relative data between the control vaccine and the negative control group, and no other significant side effects were observed. Four weeks after the first administration of the drug, there was no significant difference between the two groups. There was no significant difference in na levels of measles virus, gills virus and Japanese encephalitis virus compared with control monovalent vaccine. Conclusion M-M-JEV shows similar safety and immunogenicity to monovalent vaccine.
【作者单位】：武汉生物制品研究所有限责任公司国家联合疫苗工程技术研究中心;中国食品药品检定研究院;国家药物安全评价监测中心;
【基金】：国家高技术研究发展计划(863计划)重大项目生物和医药技术领域疫苗与抗体工程项目(编号2006AA02A233)
【分类号】：R392

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