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

威斯康星州人群流感疫苗有效性的年度估计和免疫反应评估

• 批准号: 9323277
• 负责人: EDWARD BELONGIA
• 金额: $ 110万
• 依托单位: MARSHFIELD CLINIC RESEARCH FOUNDATION
• 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/9323277
• 关键词: Annual; Estimates; Influenza; Vaccine; Effectiveness

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.

项目摘要/摘要 - 核心和附加组件 流感是发病和死亡的重要原因，流感疫苗接种是关键 流感疫苗的有效性每年都有所不同。 年，并且可能因病毒亚型、年龄组、产品类型、人群特征和 因此需要每年评估临床疫苗的有效性 评估当前疫苗建议和政策的影响，了解 病毒抗原变化与临床保护的关系及准备 大流行期间的疫苗有效性评估。 对公共卫生机构和医生有用 该项目的首要目标是进行估计。 实验室证实流感疫苗预防就医的有效性 确定的成人和儿童人群中的流感疾病患者。 流感季节期间将招募急性呼吸道疾病的门诊护理人员。 咳嗽且病程≤7天的患者在知情同意后将有资格进行鼻子检查。 咽拭子将使用核酸扩增测试（RT- PCR）样本将提供给 CDC 进行抗原表征和其他测试。 流感免疫状态将通过经过验证的免疫接种来确定。 疫苗有效性将使用案例中的测试阴性设计来计算。 包括患有 RT-PCR 确诊流感的参与者，对照组包括研究参与者 患有非流感呼吸道疾病（RT-PCR 阴性）的数据将提供给 CDC 进行分析。 与其他参与网站的综合分析，包括用于中期分析的季中数据 如果可能，将计算疫苗有效性的单独估计值。 针对不同年龄组、流感亚型和不同疫苗产品。 目的是评估该项目最后三个季节由 RSV 造成的疾病负担。 将使用 RT-PCR 检测参与者样本中的 RSV，以及医学上的发病率 第三个目标是作为应急响应资源。 用于疾病预防控制中心的疫苗接种和抗病毒药物大流行研究，这将包括准备试点研究。 为了一场大流行。