卡介苗新菌种单细胞克隆株NIFDC 945 SⅢ免疫效应及安全性的初步评价  

Preliminary evaluation on immune effect and safety of single cell clone NIFDC 945 SⅢof new BCG strain

作　　者：江秋虹 张健 程琛舒 赵爱华[2] 陶立峰 蒲江 付丽丽[2] 王国治[2] IANG Qiu-hong;ZHANG Jian;CHENG Chen-shu;ZHAO Ai-hua;TAO Li-feng;PU Jiang;FU Li-li;WANG Guo-zhi(Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.,Hefei 230088,Anhui Province,China;不详)

机构地区：[1]安徽智飞龙科马生物制药有限公司,安徽合肥230088 [2]中国食品药品检定研究院,北京102629

出　　处：《中国生物制品学杂志》2022年第6期664-667,共4页Chinese Journal of Biologicals

基　　金：国家科技重大专项(2018ZX10731301)。

摘　　要：目的初步评价卡介苗(Bacillus Calmette-Guerin vaccine,BCG)新菌种单细胞克隆株NIFDC 945 S的免疫效应及其安全性。方法将BCG NIFDC 945 S株、NIFDC 944株、D_(2)PB302株和Danish 1331株按同一条件制备成菌悬液,经小鼠尾静脉注射,于免疫后24 h及1、3、6、9、12周称量体重,无菌取小鼠脾脏,称脾重,计算脾激活指数;相同时间点进行小鼠脾组织BCG活菌计数,计算脾内BCG存活率。结果免疫后12周内,BCG NIFDC 945 S_(Ⅲ)株的脾激活指数总体上低于Danish 1331株,与NIFDC 944株和DPB302株相当;BCG NIFDC 945 S株脾内的BCG存活率总体上低于Danish 1331株和NIFDC 944株,高于D_(2)PB302株。结论BCG新菌种单细胞克隆株NIFDC 945 S具有良好的免疫效应,且安全性较高,有望成为加强型BCG候选株。Objective To preliminarily evaluate the immune effect and safety of single cell clone BCG NIFDC 945 S.Methods NIFDC 945 S_(Ⅲ),NIFDC 944,D_(2)PB302 and Danish 1331 strains of BCG were prepared into bacterial suspensions by the same production processes and injected into the tail vein of mice respectively.The mice were weighed24 h as well as 1,3,6,9 and 12 weeks after immunization,of which the spleens were collected and weighed to calculate the spleen activation index.The viable BCG in spleens at the same time points were counted to calculate the viable rate.Results Within 12 weeks after immunization,the spleen activation index of BCG NIFDC 945 S_(Ⅲ)strain was lower than that of Danish 1331 strain while was equivalent to those of NIFDC 944 and DPB302 strains in general.However,the viable rate of BCG NIFDC 945 Sstrain in spleen was lower than those of Danish 1331 and NIFDC 944strains,while was higher than that of D_(2)PB302 strain.Conclusion The new strain BCG NIFDC 945 Shas good immune effect and safety,which may be used as a candidate BCG vaccine strain for booster immunization.

关 键 词：卡介苗 单细胞克隆菌种 NIFDC 945 S 脾激活指数 活菌计数 

分 类 号：Q93-33[生物学—微生物学]