Ruan Y, Liu W, Xu X, Weng S Q, Shao S K, Zhou W Q, Teng Z, Gu H X, Zhu Z Y, Xu Z Y
Center of EPI, Chinese Academy of Preventive Medicine, Beijing 100050, China.
Zhonghua Shi Yan He Lin Chuang Bing Du Xue Za Zhi. 2001 Sep;15(3):274-6.
To compare the antibody level of vaccine group and control group in a randomized, controlled trial of type B inactivated vaccine against hemorrhagic fever with renal syndrome(HFRS) in Jiande County of Zhejiang Province and to find out if there is enhancement of subclinical infection about type B inactivated vaccine against HFRS.
The number of sera collected (July 1994-July 1998) in vaccine group immunized type B inactivated vaccine against HFRS and control group were 305 and 283 persons in Jiande County respectively, and indirect immunofluorescent antibody method(IFAT) was used for testing the titer of HFRS IgG in sera. The cut-off values were determined on IFA titer of the second sera in control group with positive and negative IFA before vaccine was given respectively, and the subclinical infection of positive and negative IFA of the first sera in vaccine group was evaluated.
When taking different cut-off values of subclinical infection, there were no statistical differences in HFRS IFA positive rates between vaccine group and control group of positive IFA in the first sera. In vaccine group and control group of negative IFA before vaccine given, also the IFA positive rates were not statistically different in these groups. There were no statistical differences of IFA GMT and IFA sero-negative rate between vaccine group and control group.
The investigation showed there was no statistical difference in antibody level between vaccine group and control group, so there could not be enhancement of subclinical infection of vaccine group receiving type B inactivated vaccine against HFRS.
在浙江省建德县进行的肾综合征出血热(HFRS)B型灭活疫苗随机对照试验中,比较疫苗组和对照组的抗体水平,以确定B型灭活疫苗针对HFRS是否存在亚临床感染增强情况。
1994年7月至1998年7月期间,在浙江省建德县,接种HFRS B型灭活疫苗的疫苗组和对照组分别采集了305人和283人的血清样本,采用间接免疫荧光抗体法(IFAT)检测血清中HFRS IgG的滴度。分别根据接种疫苗前对照组第二次血清IFA滴度的阳性和阴性情况确定临界值,并评估疫苗组第一次血清IFA阳性和阴性的亚临床感染情况。
采用不同的亚临床感染临界值时,疫苗组和对照组第一次血清IFA阳性组的HFRS IFA阳性率无统计学差异。在接种疫苗前IFA阴性的疫苗组和对照组中,这些组的IFA阳性率也无统计学差异。疫苗组和对照组之间的IFA GMT和IFA血清阴性率无统计学差异。
调查显示,疫苗组和对照组的抗体水平无统计学差异,因此接受HFRS B型灭活疫苗的疫苗组不存在亚临床感染增强情况。