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--核心部分和附加部分 流感是发病和死亡的重要原因，接种流感疫苗是关键。 流感预防的组成部分。流感疫苗的效力因年而异 它可能会因病毒亚型、年龄组、产品类型、种群特征和 抗原性匹配。因此，需要对临床疫苗的有效性进行年度评估 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防护的关系及准备 大流行期间的疫苗评估。疫苗效力的中期、中期估计 对公共卫生机构和医生很有用。该项目的第一个目标是估计 流感疫苗预防流感的有效性--由医生参与，实验室确认 确定的成人和儿童人群队列中的流感疾病。寻求治疗的患者 在流感季节，将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≤为7天的患者将符合条件。在知情同意后，鼻子 喉咙拭子将使用核酸扩增试验(RT- 聚合酶链式反应。样本将被提供给疾控中心进行抗原性鉴定和其他测试，如 恰如其分。流感免疫状态将通过有效的免疫接种来确定 注册表。疫苗效力将使用试验阴性设计计算，在以下情况下 包括RT-PCR确诊为流感的参与者，对照包括研究参与者 患有非流感呼吸系统疾病(RT-PCR阴性)。数据将提供给疾控中心，以供 与其他参与站点的综合分析，包括用于中期分析的季中数据 效率的问题。如有可能，将分别计算疫苗效力的估计值。 针对不同年龄段、流感亚型，以及不同疫苗产品。第二个目标 是评估项目最后三个季节由于RSV造成的疾病负担。 参与者样本将使用RT-PCR进行RSV检测，以及医学上 将估计参加人数的RSV。第三个目标是充当应急资源 用于疾病预防控制中心疫苗接种和抗病毒药物的大流行研究。这将包括试点研究，以准备 为大流行做准备。