一款四价流感病毒裂解疫苗在9-59岁易感人群中免疫原性和安全性的Ⅳ期临床试验

Immunogenicity and safety of a quadrivalent influenza inactivated vaccine(split-virion)in a susceptible population 9-59 years of age:a phaseⅣclinical trial

目的评价一款四价流感病毒裂解疫苗[Quadrivalent influenza inactivated vaccine(split-virion),IIV4]在9-59岁易感人群中的免疫原性和安全性。方法在贵州省某市招募9-59岁健康受试者接种1剂次IIV4,检测免疫前和免疫后28 d血清A(H1N1)、A(H3N2)、BV和BY亚型流感病毒血凝抑制(Haemagglutination inhibition,HI)抗体,分析免疫前任何亚型流感病毒抗体阴性(滴度<1:10)的受试者免疫后抗体阳转率和几何平均滴度(GMT),以及免疫后0-28 d不良事件发生率。结果受试者接种1剂次IIV4后A(H1N1)、A(H3N2)、BV、BY亚型流感病毒HI抗体阳转率分别为93.00%(332/357)、86.32%(303/351)、89.64%(545/608)、100%(8/8)(95%CI:89.84%-95.42%、82.28%-89.74%、86.94%-91.95%、63.06%-100%);GMT(1:)分别为267.65、100.59、81.94、113.14,分别是免疫前的53.53倍、20.12倍、16.39倍、22.63倍。受试者接种IIV4后与疫苗相关的不良事件发生率为10.95%(96/877),其中局部不良事件(主要为接种部位疼痛和瘙痒)、全身不良事件(主要为发热和咳嗽)分别为6.50%、5.59%;1级、2级、3级不良事件分别为7.98%、1.82%、1.14%,未发生4级或严重不良事件。结论本次临床试验显示IIV4在9-59岁易感人群中具有良好的安全性和免疫原性。

Objective To evaluate immunogenicity and safety of a quadrivalent influenza inactivated vaccine(split-virion)(IIV4)in a susceptible population aged 9-59 years.Methods We recruited healthy individuals aged 9-59 years in a prefecture of Guizhou province to administer one dose of IIV4 to each subject.We tested sera for haemagglutination inhibition(HI)antibodies against A(H1N1),A(H3N2),BV,and BY subtypes of influenza virus before and 28 days after vaccination.We analyzed seroconversion rates,geometric mean titers(GMT),and incidences of adverse events 0-28 days after vaccination among subjects who were negative to antibodies against any subtype of influenza virus(titer<1:10)before vaccination.Results Seroconversion rates of HI antibody against A(H1N1),A(H3N2),BV,and BY influenza viruses after one dose of IIV4 were 93.00%(332/357),86.32%(303/351),89.64%(545/608),and 100%(8/8),respectively(95%CIs:89.84%-95.42%,82.28%-89.74%,86.94%-91.95%,and 63.06%-100%),with GMTs(1:)being 267.65,100.59,81.94,and 113.14,which were 53.53,20.12,16.39,and 22.63 times GMTs before vaccination.The incidence of vaccination-associated adverse events was 10.95%(96/877),with 6.50%local adverse events(mainly injection-site pain and pruritus)and 5.59%systemic adverse events(mainly fever and cough).Incidences for grade 1,2,and 3 adverse events were 7.98%,1.82%,and 1.14%;no grade 4 or serious adverse events occurred.Conclusion The clinical trial showed that IIV had good safety and immunogenicity profiles among susceptible individuals aged 9-59 years.