Efficacy, safety, and immunogenicity of a Vero-cell-culture-derived trivalent influenza vaccine: a multicentre, double-blind, randomised, placebo-controlled, trial
Efficacy, safety, and immunogenicity of a Vero-cell-culture-derived trivalent influenza vaccine: a multicentre, double-blind, randomised, placebo-controlled, trial
复制标题
DOI：
10.1016/s0140-6736(10)62228-3
复制
发表时间：
2011-02-01
期刊：
影响因子：
168.9
通讯作者：
Ehrlich, Hartmut J.
中科院分区：
文献类型：
--
作者：
Barrett, P. Noel;Berezuk, Gregory;Ehrlich, Hartmut J.
使用细胞培养技术生产流感疫苗可能有助于改进毒株选择和稳定的疫苗供应。我们研究了Vero细胞培养衍生流感疫苗的安全性、免疫原性和保护效力，并评估了疫苗效力和血凝抑制抗体滴度之间的相关性。在2008-09年流感季期间，将18-49岁的受试者以1：1的比例随机分配至一次注射安慰剂或Vero细胞培养物衍生的流感疫苗。通过使用随机数生成器算法进行区组随机化，并通过使用集中电话系统分配参与者。主要目的是疫苗在预防细胞培养证实的流感病毒感染中的有效性，这些病毒与其中一种疫苗株抗原性匹配。该研究在ClinicalTrials.gov注册，编号NCT 00566345。结果7250名参与者被随机分配到疫苗组（n=3626）和安慰剂组（n=3624）。对7236例患者进行了主要结局分析（分别为n=3619和n=3617）。抗原匹配的流感病毒感染的总体保护效力为78.5%（95% CI 60.8-88.2）。该疫苗耐受性良好，没有治疗相关的严重不良事件。不良事件主要为轻度和一过性。至少1：15的HI滴度提供了细胞培养衍生的流感疫苗诱导的保护的可靠相关性;滴度大于1：30没有注意到额外的益处。解释数据表明，与蛋衍生的季节性流感疫苗提供的保护的现有相关性也适用于该疫苗。
Background 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.Methods 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.Findings 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.Interpretation The data indicate that existing correlates of protection afforded with egg-derived seasonal influenza vaccines also apply to this vaccine.