国产四价灭活流感病毒裂解疫苗在≥3岁人群中接种安全性的单中心Ⅰ期临床试验  

Safety profile of a domestic quadrivalent split influenza virus vaccine among people≥3 years old:a single-center phase I clinical trial

作　　者：韦霞 柴晶 陈建民 蒋凤 管庆虎[3] 张锐智[3] 高洪霞[2] 王明惠 王亚男 聂飞 魏绍峰 雷世光[1,3] Wei Xia;Chai Jing;Chen Jianmin;Jiang Feng;Guan Qinghu;Zhang Ruizhi;Gao Hongxia;Wang Minghui;Wang Yanan;Nie Fei;Wei Shaofeng;Lei Shiguang(School of Public Health,the key Laboratory of Environmental Pollution Monitoring and Disease Control,Ministry of Education,Guizhou Medical University,Guiyang 550025,Guizhou,China;Dalian Aleph Biomedical Co.Ltd,Dalian 116600,Liaoning,China;Guizhou Provincial Center for Disease Control and Prevention,Guiyang 550004,Guizhou,China)

机构地区：[1]贵州医科大学公共卫生与健康学院环境污染与疾病监控教育部重点实验室,贵州贵阳550025 [2]大连雅立峰生物制药有限公司,辽宁大连116600 [3]贵州省疾病预防控制中心,贵州贵阳550004

出　　处：《中国疫苗和免疫》2023年第3期268-273,共6页Chinese Journal of Vaccines and Immunization

基　　金：贵州省疾病预防控制中心2019年度术新苗培养及创新探索专项(国自然后补助资金项目)。

摘　　要：目的评价一款国产四价灭活流感病毒裂解疫苗(Quadrivalent inactivated influenza virus split vaccine,IIV4)在≥3岁人群中接种的安全性。方法采用单中心、开放性的Ⅰ期临床试验,在贵州省某县序贯入组18-59岁、≥60岁、9-17岁和3-8岁受试者,其中≥9岁各组接种1剂IIV4,3-8岁受试者分为两组接种1剂和2剂IIV4,观察每剂接种后30d内征集性/非征集性不良事件和6个月内严重不良事件。结果5个观察组各纳入20例受试者,共接种120剂次IIV4。征集性、非征集性不良事件总发生率分别为25.0%、30.0%,征集性不良事件主要为接种部位疼痛、肿胀和瘙痒以及疲乏、食欲减退、腹痛等全身症状。严重不良事件总发生率为1.7%,均与疫苗接种无关。结论Ⅰ期临床试验初步显示试验疫苗IIV4在≥3岁人群中接种安全性良好。Objective To evaluate the safety of a domestic quadrivalent inactivated influenza virus split vaccine(IIV4)among people≥3 years old.MethodsWe conducted a single-center,open-label,phase I clinical trial and sequentially enrolled 18-59-,≥60-,9-17-,and 3-8-year-olds in a county in Guizhou province.Subjects≥9 years of age received one dose of IIV4 and subjects 3-8 years of age were randomly allocated to receive either one or two doses of IIV4.We observed for solicited and unsolicited adverse events within 30 days and serious adverse events within 6 months after each dose.ResultsEach of the 5 observation groups included 20 subjects;in all,120 doses of IIV4 were administered.Overall incidences of solicited and unsolicited adverse events were 25.0%and 30.0%,respectively,most of which were injection-site pain,swelling,or pruritus,or were systemic symptoms of fatigue,loss of appetite,or stomachache.The overall incidence of serious adverse events was 1.7%,none of which were associated with the study vaccine.ConclusionsThis phase I clinical trial provided a safety profile of IIV4 in people≥3 years of age.

关 键 词：四价灭活流感病毒裂解疫苗 安全性 Ⅰ期临床试验 

分 类 号：R186[医药卫生—流行病学]