Efficacy, safety, and immunogenicity of a Vero-cell-culture-derived trivalent influenza vaccine: a multicentre, double-blind, randomised, placebo-controlled trial

流感疫苗 医学 免疫原性 安慰剂 不利影响 病毒学 维罗细胞 接种疫苗 效价 免疫学 临床终点 疫苗效力 内科学 随机对照试验 抗体 病毒 病理 替代医学
作者
Perry Barrett,Gregory P. Berezuk,Sandor Fritsch,Gerald Aichinger,Mary Kate Hart,Wael Elamin,Otfried Kistner,Hartmut J. Ehrlich
出处
期刊:The Lancet [Elsevier BV]
卷期号:377 (9767): 751-759 被引量:92
标识
DOI:10.1016/s0140-6736(10)62228-3
摘要

The use of cell-culture technologies for the manufacture of influenza vaccines might contribute to improved strain selection and robust vaccine supplies. We investigated the safety, immunogenicity, and protective efficacy of a Vero-cell-culture-derived influenza vaccine, and assessed the correlation between vaccine efficacy and haemagglutination inhibition antibody titre.In a double-blind, placebo-controlled, phase 3 trial undertaken in 36 centres in the USA, healthy adults (aged 18-49 years) were randomly assigned in a 1:1 ratio to one injection of either placebo or Vero-cell-culture-derived influenza vaccine during the 2008-09 season. Randomisation was done in blocks by use of the random number generator algorithm, and participants were allocated by use of a centralised telephone system. The primary objective was the efficacy of the vaccine in preventing cell-culture-confirmed influenza infection with viruses that were antigenically matched to one of the vaccine strains. Analysis was by intention to treat. The study is registered with ClinicalTrials.gov, number NCT00566345.7250 participants were randomly assigned to vaccine (n=3626) and placebo (n=3624). 7236 were analysed for the primary outcome (n=3619 and n=3617, respectively). Overall protective efficacy for antigenically matched influenza infection was 78·5% (95% CI 60·8-88·2). The vaccine was well tolerated with no treatment-related serious adverse events. Adverse events were mainly mild and transient. An HI titre of at least 1:15 provided a reliable correlate of cell-culture-derived influenza vaccine-induced protection; no additional benefit was noted with titres greater than 1:30.The data indicate that existing correlates of protection afforded with egg-derived seasonal influenza vaccines also apply to this vaccine.Federal (US Government) funds from the Office for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract to DynPort Vaccine Company.
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