Prospective annual estimates of influenza vaccine effectiveness and burden of disease

流感疫苗有效性和疾病负担的前瞻性年度估计

• 批准号: 9323271
• 负责人: Michael L Jackson
• 金额: $ 79.83万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9323271
• 关键词: Prospective; annual; estimates; influenza; vaccine

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.

摘要/摘要 尽管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) 每年都有很大差异，具体取决于抗原 流行病毒与疫苗株之间的匹配。指导流感的持续发展 疫苗接种建议，我们建议对流感VE、流感负担进行年度估计 疾病以及通过疫苗接种预防的病例。我们将对就医的人员进行主动监测， 预先确定的队列中经实验室确诊的流感。我们将确定寻求门诊护理的患者 急性呼吸道疾病；符合条件并同意的患者将被纳入该研究。我们将收集 对所有参与者进行呼吸道病毒检测的标本，将进行流感检测（包括型、型、 亚型和谱系）通过核酸扩增。我们将确定流感和疾病的危险因素 通过问卷和行政医疗数据库相结合的结果。我们将 通过自我报告确定受试者的流感疫苗接种史，并使用免疫登记处进行验证。 数据将与 CDC 和其他参与站点共享，以提供季中和季末 VE 估计。我们将使用测试阴性设计来估计 VE，比较不同人群接种疫苗的几率 流感检测呈阳性的受试者与检测呈阴性的受试者之间的几率。我们将每年提供 按病毒类型/亚型/谱系和年龄组分层的估计值。因为我们正在识别患者 来自特定人群的流感，我们还将在研究中估计就医流感的发病率 人口，并估计通过疫苗接种避免的流感病例数。 该项目还将作为研究新型流感病毒的 VE 和流行病学的资源， 如果在研究期间发生流感大流行。我们将与 CDC 和其他站点合作做好准备 以及流行病研究的试点测试方案。此外，该项目还为呼吸系统提供了一个平台。 合胞病毒 (RSV) 监测，可提供有关 RSV 流行病学的重要数据 RSV 疫苗的许可。我们将对标本进行 RSV 检测并估计就医的发生率 我们研究人群中的 RSV。最后，我们将利用本研究收集的数据进一步探索潜力 测试阴性设计的偏差和局限性，并预测 RSV 疫苗许可可能产生的影响 根据测试阴性研究得出的流感 VE 估计值。 拟议的研究将 1）生成数据来指导流感预防行动和 建议； 2) 在疫苗许可之前提供 RSV 发病率的基线数据； 3）增强我们的 了解测试阴性研究设计。