Prospective annual estimates of influenza vaccine effectiveness and burden of disease

摘要/摘要 虽然流感疫苗接种是减少流感引起的疾病和死亡的最佳工具， 流感疫苗的有效性（VE）每年都有很大的不同，这取决于抗原性 流行病毒和疫苗株之间的匹配指导流感的持续发展 疫苗注射建议，我们建议每年进行流行性感冒VE的估计， 疾病，以及通过接种疫苗预防的病例。我们会对有医疗护理的人进行积极的监视， 实验室确认的流感在预定义的队列。我们将确定寻求门诊护理的患者， 急性呼吸道疾病;合格且知情同意的患者将入组本研究。我们将收集 所有参与者的呼吸道病毒检测标本，将进行流感（包括类型， 亚型和谱系）。我们将确定流感的风险因素， 结果，通过问卷调查和行政保健数据库的组合。我们将 通过自我报告确定受试者的流感疫苗接种史，并使用免疫登记进行验证。 数据将与CDC和其他参与研究中心共享，以提供赛季中期和赛季末的VE 估算我们将使用测试阴性设计来估计VE，比较 流感检测阳性的受试者与检测阴性的受试者之间的比值。我们将提供年度 按病毒类型/亚型/谱系和年龄组分层的估计数。因为我们正在确认 在我们的研究中，我们还将估计医学治疗的流感的发生率 人口，并估计通过接种疫苗避免的流感病例数。 该项目还将作为研究VE和新型流感病毒流行病学的资源， 如果在研究期间发生流感大流行。我们将与疾病预防控制中心和其他网站合作， 以及大流行研究的中试方案。此外，该项目还提供了一个平台， 合胞病毒（RSV）监测，可提供RSV流行病学的重要数据， RSV疫苗许可证。我们将对标本进行RSV检测，并估计医疗护理的发病率。 RSV在我们的研究人群中。最后，我们将利用本研究收集的数据进一步探索潜力， 检测阴性设计的偏倚和局限性，并预测RSV疫苗许可的可能影响 对流感病毒VE的估计，从测试阴性研究。 拟议的研究将1）生成数据以指导流感预防行动， 建议; 2）在疫苗许可证颁发之前提供RSV发病率的基线数据;以及3）加强我们的 了解阴性试验设计。

Summary/Abstract Although influenza vaccination is the best available tool for reducing illnesses and deaths due to influenza, influenza vaccine effectiveness (VE) can vary substantially from year to year, depending on the antigenic match between circulating viruses and vaccine strains. To guide the ongoing development of influenza vaccination recommendations, we propose to conduct annual estimates of influenza VE, influenza burden of illness, and cases prevented by vaccination. We will conduct active surveillance for medically attended, laboratory-confirmed influenza in a predefined cohort. We will identify patients seeking ambulatory care for acute respiratory illness; eligible and consenting patients will be enrolled in the study. We will collect specimens for respiratory virus testing from all participants, which will be tested for influenza (including type, subtype, and lineage) via nucleic acid amplification. We will determine risk factors for influenza, and illness outcomes, through a combination of questionnaires and administrative healthcare databases. We will determine subjects' influenza vaccination history through self-report, validated using an immunization registry. Data will be shared with CDC and other participating sites to provide mid-season and end-of-season VE estimates. We will estimate VE using a test-negative design, comparing the odds of vaccination among subjects who test positive for influenza with the odds among subjects testing negative. We will provide annual estimates stratified by virus type/subtype/lineage and by age group. Because we are identifying patients with influenza from a defined cohort, we will also estimate the incidence of medically attended influenza in our study population, and estimate the number of influenza cases averted by vaccination. This project will also serve as a resource for studying VE and epidemiology of a novel influenza virus, should an influenza pandemic occur during the study period. We will work with CDC and other sites to prepare and pilot-test protocols for pandemic studies. In addition, this project provides a platform for respiratory syncytial virus (RSV) surveillance, which can provide important data on the epidemiology of RSV prior to licensure of RSV vaccines. We will test specimens for RSV and estimate the incidence of medically attended RSV in our study population. Finally, we will use data collected from this study to further explore potential biases and limitations of the test-negative design and to anticipate possible effects of RSV vaccine licensure on influenza VE estimates from test-negative studies. The proposed research will 1) generate data to guide influenza prevention actions and recommendations; 2) provide baseline data on RSV incidence prior to vaccine licensure; and 3) enhance our understanding of the test-negative study design.