Safety and immunogenicity of a quadrivalent inactivated influenza vaccine compared to licensed trivalent inactivated influenza vaccines in adults
Safety and immunogenicity of a quadrivalent inactivated influenza vaccine compared to licensed trivalent inactivated influenza vaccines in adults
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DOI：
10.1016/j.vaccine.2012.11.074
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发表时间：
2013-01-21
期刊：
影响因子：
5.5
通讯作者：
Decker, Michael D.
中科院分区：
文献类型：
--
作者：
Greenberg, David P.;Robertson, Corwin A.;Decker, Michael D.
目的：评价含有两株乙型流感病毒株(各一株)的原型四价灭活流感疫苗(QIV)的安全性和免疫原性，并与含有B型流感疫苗维多利亚株(2009-2010)或山形B株(2008-2009)的特许三价灭活疫苗(TIV)进行比较。参与者接受了单剂2009-2010年TIV、2008-2009 TIV或QIV。在接种疫苗前和接种后第21天分别采集血清，检测四种流感病毒株的血凝抑制(HAI)抗体。免疫原性终点包括几何平均HAI抗体滴度(GMT)和血清保护率(滴度和效价=1：40)和血清转换率(接种前后增加4倍)。安全终点包括接种后3天内主动注射部位和全身反应发生的频率，以及接种后21天内主动出现的非严重不良事件和严重不良事件。结果：每组有190名参与者。QIV对每个A和B毒株诱导的GMT不低于2009-2010和2008-2009 TIV诱导的GMT(即，每个毒株GMT(QIV)/GMT(TIV)和GT；0.66的双边95%可信区间的下限)。所有组的血清保护率和血清转换率都是相似的。不同组间请求注射部位和全身反应、不良反应和不良反应的发生率和严重程度相似。结论：QIV包含两株B株(每个B系一株)，与许可的TIV一样安全和具有免疫原性。QIV有可能成为TIV的一种有用的替代方案，并提供对两种B血统的保护。(C)2012爱思唯尔有限公司。保留所有权利。
Purpose: To evaluate the safety and immunogenicity of a prototype quadrivalent inactivated influenza vaccine (QIV) containing two influenza B strains, one of each lineage, compared with licensed trivalent inactivated influenza vaccines (TIVs) containing either a Victoria B-lineage strain (2009-2010 TIV) or a Yamagata B-lineage strain (2008-2009 TIV).Methods: Healthy adults >= 18 years of age were eligible to participate in this phase II, open-label, randomized, controlled, multicenter study conducted in the US. Participants received a single dose of 2009-2010 TIV, 2008-2009 TIV, or QIV. Sera were collected before and 21 days after vaccine administration to test for hemagglutination inhibition (HAI) antibodies to each of the four influenza strains. Immunogenicity end-points included geometric mean HAI antibody titers (GMTs) and rates of seroprotection (titer >= 1:40) and seroconversion (4-fold rise pre- to post-vaccination). Safety endpoints included frequency of solicited injection-site and systemic reactions occurring within 3 days of vaccination, and unsolicited non-serious adverse events (AEs) and serious AEs (SAEs) within 21 days of vaccination.Results: One hundred and ninety participants were enrolled to each vaccine group. QIV induced GMTs to each A and B strain that were noninferior to those induced by the 2009-2010 and 2008-2009 TIVs (i.e., lower limit of the two-sided 95% confidence interval of the ratio of GMT(QIV)/GMT(TIV) > 0.66 for each strain). Rates of seroprotection and seroconversion were similar in all groups. Incidence and severity of solicited injection-site and systemic reactions, AEs, and SAEs were similar among groups.Conclusion: QIV, containing two B strains (one from each B lineage), was as safe and immunogenic as licensed TIV. QIV has the potential to be a useful alternative to TIV and offer protection against both B lineages. (C) 2012 Elsevier Ltd. All rights reserved.