CAJ | 학술논문

目的观察乙型脑炎(乙脑)减毒活疫苗的接种反应和免疫原性.方法分别选择52名(8月龄～50岁)和607名(8月龄～12岁)健康志愿者进行Ⅰ和Ⅲ期临床试验.试验组每人接种1次由上海生物制品研究所有限责任公司研制的乙脑减毒活疫苗(0.5 ml),对照组接种同样剂量的已上市乙脑减毒活疫苗.两组接种后的不良反应率和中和抗体阳转率用x2检验进行比较,中和抗体几何平均滴度用t检验进行比较.结果试验组接种后有5.91％的人体温升高,对照组为7.96％,两组的体温反应发生率差异无统计学意义(x2 =0.917,P=0.338).试验组Ⅰ期试验局部反应率为1.92％,Ⅲ期试验为0.25％,对照组Ⅲ期试验局部反应率为0.50％,两组的局部反应率差异无统计学意义(确切概率法,P=0.553).Ⅲ期免疫原性试验中,试验组的血清中和抗体阳转率为89.00％,抗体几何平均滴度为29.69;而对照组分别为74.59％和19.25,差异均有统计学意义(x2=11.708,P=0.001;t=4.281,P=0.001).结论本研究的试验性乙脑减毒活疫苗接种反应轻微,并具有良好的免疫原性.
목적 관찰을형뇌염(을뇌)감독활역묘적접충반응화면역원성.방법 분별선택52명(8월령～50세)화607명(8월령～12세)건강지원자진행Ⅰ화Ⅲ기림상시험.시험조매인접충1차유상해생물제품연구소유한책임공사연제적을뇌감독활역묘(0.5 ml),대조조접충동양제량적이상시을뇌감독활역묘.량조접충후적불량반응솔화중화항체양전솔용x2검험진행비교,중화항체궤하평균적도용t검험진행비교.결과 시험조접충후유5.91％적인체온승고,대조조위7.96％,량조적체온반응발생솔차이무통계학의의(x2 =0.917,P=0.338).시험조Ⅰ기시험국부반응솔위1.92％,Ⅲ기시험위0.25％,대조조Ⅲ기시험국부반응솔위0.50％,량조적국부반응솔차이무통계학의의(학절개솔법,P=0.553).Ⅲ기면역원성시험중,시험조적혈청중화항체양전솔위89.00％,항체궤하평균적도위29.69;이대조조분별위74.59％화19.25,차이균유통계학의의(x2=11.708,P=0.001;t=4.281,P=0.001).결론 본연구적시험성을뇌감독활역묘접충반응경미,병구유량호적면역원성.
Objective To observe adverse reaction and immunogenicity of an attenuated Japanese encephalitis live vaccine for human use.Methods Phases Ⅰ and Ⅲ clinical trials were performed in 52 healthy volunteers aged between 8 months and 50 years and 607 children aged between 8 months and 12 years,respectively.Subjects were inoculated with 1 dose (0.5 ml) of the test vaccine.A licensed vaccine was used as control.The rates of adverse reaction and seroconversion between the test and control groups were compared with chi-square test.Geometric mean titer (GMT) of neutralizing antibody was compared with t-test between the two groups.Results The rates of rise in temperature were 5.91％ and 7.96％ in the test group and control group,respectively.There was no statistical difference between the two groups (x2=0.917,P=0.338).The rates of local reaction in test group were 1.92％ and 0.25％in Phases Ⅰ and Ⅲ,respectively,compared with 0.50％ in control group in Phase Ⅲ.No significant difference was found between the two groups (exact probability,P=0.553).The seroconversion rates and GMT of neutralizing antibody in test group were 89.00％ and 29.69,compared with 74.59％ and 19.25 in control group (x2 =11.708,P=0.001; t=4.281,P=0.001).Conclusion The test vaccine is proved to be safe and immunogenic.