Global Research and Development, Baxter BioScience, Biomedical Research Centre, Orth/Donau, Austria.
Lancet. 2011 Feb 26;377(9767):751-9. doi: 10.1016/S0140-6736(10)62228-3. Epub 2011 Feb 15.
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.
细胞培养技术在流感疫苗生产中的应用可能有助于改善菌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，并评估了疫苗效力与血凝抑制抗体滴度之间的相关性。
在一项在美国 36 个中心进行的双盲、安慰剂对照、3 期试验中，健康成年人（年龄 18-49 岁）在 2008-09 季节以 1:1 的比例随机分配接受安慰剂或 vero 细胞培养衍生流感疫苗的单次注射。通过使用随机数生成器算法进行分组随机化，通过中央电话系统分配参与者。主要目的是评估疫苗预防与疫苗株之一具有抗原匹配的病毒引起的细胞培养确认的流感感染的效力。分析采用意向治疗。该研究在 ClinicalTrials.gov 注册，编号为 NCT00566345。
7250 名参与者被随机分配到疫苗组（n=3626）和安慰剂组（n=3624）。7236 名参与者被分析用于主要结局（n=3619 和 n=3617）。抗原匹配的流感感染的总体保护效力为 78.5%（95%CI 60.8-88.2）。疫苗具有良好的耐受性，无与治疗相关的严重不良事件。不良事件主要为轻度和短暂。血凝抑制抗体滴度至少为 1:15 是细胞培养衍生流感疫苗诱导保护的可靠相关物；滴度大于 1:30 没有额外的益处。
数据表明，现有蛋源性季节性流感疫苗提供的保护相关性也适用于这种疫苗。
联邦（美国政府）资金来自准备和应对办公室、生物医学高级研究与发展局，根据 DynPort 疫苗公司的合同提供。
