LT70-DPC结核亚单位疫苗安全性的初步评价Safety of tuberculosis subunit vaccine LT70-DPC
何娟娟;胡丽娜;刘勋;王秉翔;张婷婷;祝秉东;
摘要(Abstract)：
目的初步评价以阳离子脂质体二甲基三十六烷基铵(dimo-thylidioctyl ammonium bro-mide,DDA)、聚肌胞苷酸(Poly I∶C)及胆固醇复合佐剂(简称为DPC)为佐剂的结核融合蛋白ESAT6-Ag85B-MPT64(190-198)-Mtb8.4-Rv2626c(LT70)亚单位疫苗的安全性。方法急性毒性试验:分别将低剂量与高剂量(分别相当于人用剂量的10 000和40 000倍)的LT70-DPC结核亚单位疫苗经皮下、腹腔两种途径免疫小鼠,观察小鼠毒性反应、死亡情况及体重变化等,同时推算小鼠对LT70-DPC亚单位疫苗的最大耐受剂量(maximum tolerated dose,MTD);异常毒性试验:将小鼠和豚鼠分别经腹腔注射LT70-DPC结核亚单位疫苗,观察动物异常反应、死亡情况及体重变化等;全身过敏试验:豚鼠经LT70-DPC结核亚单位疫苗免疫后,经相应疫苗静脉攻击,观察豚鼠过敏反应。结果急性毒性试验:皮下及腹腔注射后14 d内均未见小鼠的异常反应和死亡,体重均增加,小鼠对该疫苗的MTD为:LT70蛋白>6 600μg/kg,DDA>166 600μg/kg,Poly I∶C>33 200μg/kg,胆固醇>50 600μg/kg;异常毒性试验:注射后7 d内,小鼠及豚鼠全部健存,均未出现异常症状,体重增加;全身过敏试验:攻击后1 h内,豚鼠均未出现过敏反应。结论 LT70-DPC结核亚单位疫苗具有良好的安全性。
关键词(KeyWords)： LT70-DPC结核亚单位疫苗;安全性
基金项目(Foundation): 国家传染病防治科技重大专项(2012ZX10003-008-006)
作者(Author): 何娟娟;胡丽娜;刘勋;王秉翔;张婷婷;祝秉东;
Email:
DOI: 10.13200/j.cnki.cjb.001602
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