Annual Estimates of Influenza Vaccine Effectiveness and Evaluation of Immune Response in a Wisconsin Population

项目概要/摘要-核心和附加组件 流感是发病和死亡的重要原因，接种流感疫苗是关键 预防流感的组成部分。流感疫苗的有效性每年不同， 它可能因病毒亚型、年龄组、产品类型、人群特征和 抗原匹配因此，需要每年评估疫苗的临床有效性， 评估当前疫苗建议和政策的影响，了解 病毒抗原性变化与临床保护的关系， 大流行期间的疫苗评估。疫苗有效性的中期估计 对公共卫生机构和医生都很有用。该项目的第一个目标是估计 流感疫苗对预防流感的有效性已得到医疗护理，实验室证实 在成人和儿童的确定人群队列中的流感疾病。患者寻求 将在流感季节招募急性呼吸道疾病的门诊护理人员。 咳嗽和疾病持续时间≤7天的患者将有资格参加。知情同意后，鼻 和咽拭子将使用核酸扩增试验（RT-PCR）检测甲型和B型流感病毒。 PCR）。样本将提供给CDC进行抗原表征和其他检测， 适当流感免疫状态将通过经验证的免疫接种确定 注册表将使用试验阴性设计计算疫苗有效性，其中病例 包括RT-PCR证实流感参与者和包括研究参与者的对照 非流感性呼吸道疾病（RT-PCR阴性）。数据将提供给CDC， 与其他参与研究中心的联合分析，包括中期分析的季中数据 效率。如有可能，将计算疫苗有效性的单独估计值 针对不同的年龄组、流感亚型和不同的疫苗产品。第二个目的 是评估在项目的最后三个季节期间由于RSV引起的疾病负担。 将使用RT-PCR检测受试者样本的RSV，并在受试者中检测医学感染的发生率。 将估计参加的RSV。第三个目标是作为应急资源 用于疾病预防控制中心的疫苗和抗病毒药物的流行病研究。这将包括试点研究， 一场大流行

Project Summary/Abstract - Core and Additional Components Influenza, an important cause of morbidity and mortality, and influenza vaccination are key components of influenza prevention. The effectiveness of influenza vaccine varies from year to year, and it can vary by virus subtype, age group, product type, population characteristics, and antigenic match. Annual assessment of clinical vaccine effectiveness is therefore needed to evaluate the impact of current vaccine recommendations and policies, understand the relationship between antigenic changes in viruses and clinical protection, and prepare for vaccine assessment during a pandemic. Interim, mid-season estimates of vaccine effectiveness are useful for public health agencies and physicians. The first Aim of the project is to estimate the effectiveness of influenza vaccine for preventing medically-attended, laboratory confirmed influenza illness in a defined population cohort of adults and children. Patients who seek outpatient care for acute respiratory illness will be recruited during the influenza season. Patients with cough and illness duration ≤7 days will be eligible. After informed consent, nose and throat swabs will be tested for influenza A and B using a nucleic acid amplification test (RT- PCR). Samples will be provided to CDC for antigenic characterization and other tests as appropriate. Influenza immunization status will be determined by a validated immunization registry. Vaccine effectiveness will be calculated using the test negative design where cases include participants with RT-PCR confirmed influenza and controls include study participants with noninfluenza respiratory illness (negative RT-PCR). Data will be provided to CDC for combined analyses with other participating sites, including mid-season data for interim analysis of effectiveness. When possible, separate estimates of vaccine effectiveness will be calculated for different age groups, influenza subtypes, and for different vaccine products. The second Aim is to evaluate the disease burden due to RSV during the last three seasons of the project. Participant samples will be tested for RSV using RT-PCR, and the incidence of medically attended RSV will be estimated. The third Aim is to serve as an emergency response resource for CDC pandemic studies of vaccination and antivirals. This will include pilot studies to prepare for a pandemic.