6-11月龄婴儿联合接种肠道病毒71型灭活疫苗和三价灭活流感裂解疫苗的免疫原性和安全性  

Immunogenicity and safety of co-vaccination with inactivated enterovirus 71 vaccine and trivalent inactivated influenza split vaccine among 6-11-month-old infants

作　　者：刘吴靖 李羽敏[1] 徐伟钗 黄金波[1] 洪浚扉 董升草[1] Liu Wujing;Li Yumin;Xu Weichai;Huang Jinbo;Hong Junfei;Dong Shengcao(Lishui Municipal Center for Disease Control and Prevention,Lishui 323000,Zhejiang,China;Liandu District Center for Disease Control and Prevention,Lishui 323000,Zhejiang,China)

机构地区：[1]丽水市疾病预防控制中心,浙江丽水323000 [2]莲都区疾病预防控制中心,浙江丽水323000

出　　处：《中国疫苗和免疫》2023年第3期261-267,共7页Chinese Journal of Vaccines and Immunization

基　　金：丽水市2020年市本级公益性技术研究自筹项目(2020SJZC020)。

摘　　要：目的评价6-11月龄婴儿联合接种肠道病毒71型灭活疫苗(Enterovirus 71 inactivated vaccine,EV71V)和三价灭活流感裂解疫苗(Trivalent inactivated influenza split vaccine,IIV3)的免疫原性和安全性。方法在丽水市某区招募6-11月龄健康儿童,随机分为EV71V+IIV3、EV71V和IIV3接种组,按0-1月免疫程序接种2剂次相应疫苗,观察每剂次免疫后30d内不良事件,采集免疫前和免疫后28-37d血清标本,检测EV71和A(H1N1)/H3N2/B型流感病毒抗体,比较抗体阳转率、几何平均滴度(Geometric mean titer,GMT)和不良事件发生率。结果三个组各纳入126名受试者。EV71V+IIV3组、EV71V组免疫后EV71抗体阳转率均为100%,GMT(1:)分别为368.55、427.56,分别是免疫前的74.27倍、85.96倍。EV71V+IIV3组、IIV3组免疫后A(H1N1)/H3N2/B型流感病毒抗体阳转率分别为98.31%/100%/99.15%、97.54%/100%/99.18%,两组阳转率的率差分别为0.76%(95%CI:-2.84%-4.37%)、0.00%、-0.03%(95%CI:-2.33%-2.27%);GMT(1:)分别为112.49/119.29/56.90、113.14/121.12/60.56,分别是免疫前的21.09/23.16/11.38倍、22.37/22.24/12.11倍。三个组不良事件发生率分别为4.45%、6.43%、4.78%(95%CI:2.63%-6.27%、3.38%-9.48%、2.14%-7.42%),无严重不良事件报告。结论6-11月龄婴儿联合接种EV71V和IIV3具有良好的免疫原性和安全性。Objective To evaluate immunogenicity and safety of co-vaccination with inactivated enterovirus 71 vaccine(EV71V)and trivalent inactivated influenza split vaccine(IIV3)among 6-11-month-old infants.MethodsWe recruited 6-11-month-old healthy infants in a district of Lishui city and randomized them into EV71V+IIV3,EV71V,and IIV3 groups.Each subject received 2 doses of relevant vaccines in a 0-1-month immunization schedule.We observed for adverse events within 30 days after each dose and tested sera for EV71 and A(H1N1)/H3N2/B influenza virus antibodies before and 28-37 days after vaccination.We compared antibody seroconversion rates,geometric mean titers(GMTs),and adverse event incidences.ResultsEach group included 126 subjects.Seroconversion rates of EV71 antibody in the EV71V+IIV3 and EV71V groups were both 100%;respective GMTs(1:)were 368.55 and 427.56,which were 74.27 and 85.96 times higher than before vaccination.Seroconversion rates of A(H1N1)/H3N2/B influenza virus antibodies in EV71V+IIV3 and IIV3 groups were 98.31%/100%/99.15%and 97.54%/100%/99.18%,with differences of 0.76%(95%CI:-2.84%-4.37%),0.00%,and-0.03%(95%CI:-2.33%-2.27%);GMTs(1:)were 112.49/119.29/56.90 and 113.14/121.12/60.56,which were 21.09/23.16/11.38 and 22.37/22.24/12.11 times higher than before vaccination.Adverse event incidences in the three groups were 4.45%,6.43%,and 4.78%(95%CIs:2.63%-6.27%,3.38%-9.48%,and 2.14%-7.42%);no serious adverse events were reported.ConclusionsCo-vaccination with EV71V and IIV3 in 6-11-month-old infants showed good immunogenicity and safety profiles.

关 键 词：肠道病毒71型灭活疫苗 三价灭活流感裂解疫苗 联合接种 免疫原性 安全性 

分 类 号：R186[医药卫生—流行病学] R725.1[医药卫生—公共卫生与预防医学]