李萍萍;李伟;刘胜;屈哲;齐卫红;贾丽丽;易玲;王月;

• 1:武汉生物制品研究所有限责任公司
• 2:国家联合疫苗工程技术研究中心
• 3:中国食品药品检定研究院/国家药物安全评价监测中心
• 4:中国食品药品检定研究院

摘要(Abstract)：

目的进行麻疹-流行性乙型脑炎(乙脑)联合减毒活疫苗(Measles and Japanese Encephalitis Combined Attenuated Live Vaccine,M-JEV)的安全性评价。方法小鼠急性毒性试验:设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-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3周和4周,麻疹病毒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-JEV表现出与单价疫苗相似的安全性和免疫原性。

关键词(KeyWords)： 麻疹-流行性乙型脑炎联合减毒活疫苗;安全性评价;长期毒性;免疫原性;局部刺激性;急性毒性

Abstract:

Keywords:

基金项目(Foundation): 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);; 生物技术领域疫苗研发关键技术及产品研发项目(编号2012AA02A401)

作者(Authors): 李萍萍;李伟;刘胜;屈哲;齐卫红;贾丽丽;易玲;王月;

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