四价流感病毒亚单位疫苗在3-64岁人群中的免疫原性评价

Immunogenicity of quadrivalent influenza virus subunit vaccine in a population aged 3-64 years

目的评价四价流感病毒亚单位疫苗在3~64岁健康人群中接种后的免疫原性。方法选择3~64岁的健康人群为研究对象,采用随机、盲法、阳性对照的非劣效试验,招募受试者后按1∶1随机接种相对应的实验疫苗或对照疫苗,受试者全程接种1剂。采集所有受试者免疫前和全程免疫后28 d的血样,血凝抑制(hemagglutination inhibition,HI)试验检测流感病毒H1N1、H3N2、B/Victoria(BV)和B/Yamagata(BY)血清抗体水平,分析抗体几何平均滴度(geometric mean titer,GMT)增长倍数、抗体阳转率和抗体保护率。结果符合方案分析集的共有3~64岁受试者2157例,其中实验组1074例,对照组1083例。两组受试者免疫前H1N1、H3N2、BV和BY型抗体GMT和抗体保护率差异均无统计学意义(P>0.05),两组基线均衡。全程免疫后,实验组各型别抗体GMT增长倍数分别为11.16、17.77、9.61和15.13,抗体阳转率分别为84.08%(903/1074)、92.46%(993/1074)、86.03%(924/1074)和91.71%(985/1074),抗体保护率分别为96.74%(1039/1074)、97.58%(1048/1074)、88.08%(946/1074)和94.97%(1020/1074)。实验组4个型别抗体GMT均较免疫前增长2.5倍以上,抗体阳转率95%CI下限均>40%,抗体保护率95%CI下限均>70%;实验疫苗与对照疫苗4个型别抗体的阳转率率差的95%CI下限均>-10%,GMT实验组/GMT对照组的95%CI下限均>2/3。结论在3~64岁人群中,实验疫苗具有较好的免疫原性,且非劣效于对照疫苗。

ObjectiveTo evaluate the immunogenicity of a quadrivalent influenza virus subunit vaccine in a healthy population aged 3-64 years.MethodsHealthy people aged 3-64 years old were selected as the study subjects,and a randomized,blind,positive controlled,non-inferiority test was adopted.The subjects were randomly inoculated with one dose of the corresponding experimental vaccine or control vaccine in a ratio of 1∶1.Blood samples were collected from all subjects before and at 28 d after immunization,and hemagglutination inhibition(HI)test was used to measure the levels of antibodies against H1N1,H3N2,B/Victoria(BV)and B/Yamagata(BY)in serum.The geometric mean titers(GMT),geometric mean increase(GMI),positive conversion rates and protection rates of antibodies against the four types of viruses were analyzed.ResultsA total of 2157 subjects aged 3-64 years were included,including 1074 in the experimental group and 1083 in the control group.There were no significant differences in the GMT or protection rates of antibodies against H1N1,H3N2,BV or BY before immunization between the two groups(P>0.05),and the two groups were balanced at baseline.After full immunization,the GMI of antibodies to H1N1,H3N2,BV and BY in the experimental group was 11.16,17.77,9.61 and 15.13,respectively;the positive conversion rates were 84.08%(903/1074),92.46%(993/1074),86.03%(924/1074)and 91.71%(985/1074),respectively;the protection rates were 96.74%(1039/1074),97.58%(1048/1074),88.08%(946/1074)and 94.97%(1020/1074),respectively.In the experimental group,the GMT of each antibody increased by more than 2.5 times after immunization;the lower limit of the 95%CI of the positive conversion rate was higher than 40%,and the lower limit of the 95%CI of the protection rate was higher than 70%.The lower limit of the 95%CI of the difference in the positive conversion rate of each antibody between the experimental group and the control group was>-10%,and the lower limit of the 95%CI for GMT(experimental group)/GMT(control group)was over 2/3.ConclusionsThe experimental vaccine had good immunogenicity and was non-inferior to the control vaccine in the population aged 3-64 years.