Antibody induction by virosomal, MF59-adjuvanted, or conventional influenza vaccines in the elderly
Antibody induction by virosomal, MF59-adjuvanted, or conventional influenza vaccines in the elderly
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DOI：
10.1016/j.vaccine.2007.10.051
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发表时间：
2007-12-21
期刊：
影响因子：
5.5
通讯作者：
Palache, Bram
中科院分区：
文献类型：
--
作者：
de Bruijn, Iris;Meyer, Ingo;Palache, Bram
在一项随机、双盲、三臂、平行组、多中心试验中，包括4个国家的386名老年受试者，研究了3种不同的三价灭活表面抗原（亚单位）流感疫苗类型的免疫原性和安全性：常规亚单位流感疫苗（SIV，品牌：Influvac（R））和两种较新的疫苗：MF 59佐剂亚单位流感疫苗（adSIV，品牌：Fluad（R））和病毒体亚单位流感疫苗（vSIV，品牌：Invivac（R））。所有疫苗均为三价疫苗，按照世界卫生组织2004-2005年季节的建议，每种病毒株含15 μ g血凝素。本研究旨在证明vSIV在老年人中的血清学非劣效于adSIV和SIV。次要目的是研究vSIV在局部反应原性方面是否上级adSIV。对于所有三种疫苗株，SIV和adSIV之间以及vSIV和SIV之间的接种后几何平均滴度相当。血清保护率（即接种后滴度>= 40的受试者百分比）在84.1-100%之间变化，表明三种疫苗均诱导了强烈的抗体应答。与vSIV或SIV（相似于20%）相比，adSIV（分别为46%和32%）更常见的局部和全身反应。根据问卷调查，疫苗接种只造成很少的不便。总体而言，所有疫苗均安全且耐受性良好，在本试验中，病毒体疫苗的免疫原性与MF 59佐剂和常规亚单位疫苗相似，但在老年人中的反应原性明显低于MF 59佐剂疫苗。(c)2007爱思唯尔有限公司保留所有权利。
In a randomized, observer-blind, three-arm, parallel group, multi-centre trial including 386 elderly subjects in four countries, the immunogenicity and safety was studied of three different trivalent inactivated surface antigen (subunit) influenza vaccine types: a conventional subunit influenza vaccine (SIV, brand: Influvac (R)) and two newer vaccines: a MF59-adjuvanted subunit influenza vaccine (adSIV, brand: Fluad (R)) and a virosomal subunit influenza vaccine (vSIV, brand: Invivac (R)). All vaccines were trivalent containing 15 mu g hemagglutinin of each virus strain as recommended by the World Health Organization for the 2004-2005 season. The study was designed to demonstrate the serological non-inferiority of vSIV to both adSIV and SIV in elderly persons. The secondary objective was to investigate whether vSIV is superior to adSIV with respect to local reactogenicity.For all three vaccine strains, the post-vaccination geometric mean titres were comparable between SIV and adSIV and between vSIV and SIV. Seroprotection rates (i.e. percentages of subjects with a post-vaccination titre >= 40) varied between 84.1-100% indicating that the three vaccines all induced a strong antibody response.Local and systemic reactions were more frequently associated with adSIV (46 and 32%, respectively) than with vSIV or SIV (similar to 20%). Vaccinations caused only little inconvenience as measured by questionnaire. In general, all vaccines were safe and well tolerated.In this trial, virosomal vaccine had similar immunogenicity to MF59-adjuvanted and conventional subunit vaccine and was considerably less reactogenic than the MF59-adjuvanted vaccine in the elderly. (c) 2007 Elsevier Ltd. All rights reserved.