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: 10179278
• 负责人: Michael L Jackson
• 金额: $ 50万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10179278
• 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由于流感引起的疾病和死亡的最佳工具，但 流感疫苗有效性（VE）每年都可能有很大差异，具体取决于抗原 循环病毒和疫苗菌株之间匹配。指导流感的持续发展 疫苗接种建议，我们建议对流感VE进行年度估计，流感负担 疾病和疫苗接种阻止的病例。我们将进行主动监视，以供医学上参加， 实验室确认的预定义人群中的流感。我们将确定寻求门诊护理的患者 急性呼吸道疾病；符合条件和同意的患者将参加该研究。我们将收集 所有参与者的呼吸道病毒测试标本 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 结果，通过问卷和行政医疗保健数据库的结合。我们将 通过自我报告确定受试者的流感疫苗接种历史，并使用免疫注册表进行了验证。 数据将与疾病预防控制中心和其他参与网站共享，以提供季节和季末VE 估计。我们将使用测试阴性设计估算VE，并比较疫苗接种的几率 对流感呈阳性的受试者，受试者测试阴性的几率。我们将提供年度 通过病毒类型/亚型/谱系和年龄组分层的估计值。因为我们正在识别患者 来自定义的队列的流感，我们还将在我们的研究中估计医学上参加的流感的发生率 人口，并估计通过疫苗接种避免的流感病例的数量。 该项目还将作为研究一种新型流感病毒的VE和流行病学的资源，即 如果在研究期间发生流感大流行。我们将与CDC和其他网站合作准备 和大流行研究的试点测试方案。此外，该项目还提供了呼吸道的平台 合成病毒（RSV）监测，可以在RSV的流行病学之前提供重要数据 RSV疫苗的许可。我们将测试RSV的标本，并估算出在医学上的发病率 RSV在我们的研究人群中。最后，我们将使用本研究收集的数据进一步探索潜力 测试阴性设计的偏见和局限性，并预测RSV疫苗许可的可能影响 关于测试阴性研究的流感估计。 拟议的研究将1）生成数据以指导预防流感的动作和 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 了解测试负研究设计。