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作 者:赵秦[1] 靳毅[1] 余黎[1] 包红[1] 胡广宏[1] 安红[1] 李益民[1] 方捍华[2] 李薇[2]
机构地区:[1]兰州生物制品研究所,兰州730046 [2]中国药品生物制品检定所,北京100050
出 处:《微生物学免疫学进展》2001年第3期30-34,共5页Progress In Microbiology and Immunology
摘 要:通过对兰州生物制品研究所试生产的流行性感冒灭活疫苗的人体试验研究。兰州所流感灭活疫苗接种后 ,所有接种对象均未见红肿、硬结等局部反应 ,仅有 1例发生在儿童组的低热全身反应 (体温 37 4℃ ) ,72小时后恢复正常 ,整体副反应发生率 0 2 74% ,肯定了该疫苗的安全性。疫苗接种前后易感人群血清血凝抑制 (HI)抗体阳转率 10 0 %。非易感人群HI抗体几何平均效价 (GMT)增长 19~ 6 0倍 ;抗体 4倍增长率最低为 95 % ,成人组平均值最高 (97 6 7% )。证实该疫苗具有较好的免疫原性。The clinical trial of inactivated influenza virus vaccine were undertaken by Lanzhou Institute of Biological Products.No partical reaction such as redness and swelling occurred at the inoculation site,only one of subject in clildren had a low fever(temperature 37.4℃)and recovered in 72 hours.The undesirable reaction rates of entire subjects were 0.274% .The antibody titers were determined by hemagglutination inhibition(HI)test.The comparison between pre and postvaccination showed that the responsive rates of sensitive subjects were about 100%,the HI geometric mean titers(GMT)were all increased 19 60 folds among insensitive subjects,and the fourfold rise rates(FRR)of antibody HI titers were not less than 95%(adults got the highest mean value of 97.6%).The study demonstrated that this newly prepared vaccine had a desirable immunogenecity in relation to large scale vaccination.
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