Annual Estimates of Influenza Vaccine Effectiveness: Davidson County, TN

流感疫苗有效性的年度估计：田纳西州戴维森县

• 批准号: 7568033
• 负责人: MARIE R. GRIFFIN
• 金额: $ 93.87万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7568033
• 关键词: Annual; Estimates; Influenza; Vaccine; Effectiveness

DESCRIPTION (provided by investigators): Each year influenza viruses infect 5 to 20% of the US population and cause an annual average of 226,000 hospitalizations and 34,000 deaths. Annual influenza vaccination recommendations traditionally targeted persons aged >65 years; others with medical conditions that also place them at high-risk for influenza- associated complications; and close contacts of those considered "high-risk." These recommendations have recently expanded to include adults aged 50 to 64 years and children aged 6 months to <5 years. These public policy recommendations, which now include the majority of the US population, require careful evaluation to assure that they are having their intended effects. Because influenza viruses and vaccines change annually, annual assessments of vaccine effectiveness are needed. For the past eight years, we have participated in population-based surveillance for influenza in young children with acute respiratory illness in Nashville, Davidson County (population 578,698) as part of the CDC's New Vaccine Surveillance Network. With two years of support from NIH's Vaccine Treatment and Evaluation Unit, we initiated similar surveillance for adults aged >50 years during the 2006-7 influenza season, which will continue through the 2007-8 season. Our experience uniquely qualifies us to efficiently initiate the surveillance activities needed to perform annual assessments of vaccine effectiveness. We have established relationships with Davidson County hospitals that provide care to >95% of county children and >50% of county adults hospitalized with acute respiratory illness. The procedures for enrolling and testing eligible patients have been established, data collection forms developed and field-tested, and laboratory procedures refined and validated. We propose to perform active population-based surveillance for laboratory confirmed influenza in adults and children in order to determine age-specific rates of influenza-associated hospitalizations and emergency department visits in the county. We will work with CDC and other cooperative agreement participants to assess influenza vaccine effectiveness twice annually, once in the middle of influenza season and once at the season's end. We propose a matched case control analysis to assess vaccine effectiveness. Study subjects will be a systematic sample of county children and adults aged 6 months or older with a hospitalization or emergency room visit for acute respiratory illness. Enrolled subjects will contribute nose and throat swabs for influenza testing in the research laboratory. Subjects or their parents/guardians will provide information about their acute illness, medical history, and influenza vaccination status. Cases will be defined by detection of influenza virus by reverse transcriptase- polymerase chain reaction (RT-PCR) or viral culture. All study subjects that test negative for influenza by both RT-PCR and culture will be eligible to be controls. In year one, we also will collect, process, store, and ship to CDC, 450 paired sera and150 paired peripheral blood mononuclear cell specimens to assess both humoral and cellular immune responses to influenza vaccines among adults aged >50 years.

描述（由调查人员提供）：每年流感病毒感染5%至20%的美国人口，每年平均造成226,000人住院，34,000人死亡。每年流感疫苗接种的建议传统上针对的是年龄在100至65岁之间的人；其他患有流感相关并发症高风险疾病的人；以及那些被认为是“高危人群”的密切接触者。这些建议最近已扩大到包括50至64岁的成年人和6个月至5岁以下的儿童。这些公共政策建议现在包括了大多数美国人，需要仔细评估，以确保它们产生了预期的效果。由于流感病毒和疫苗每年都会发生变化，因此需要每年对疫苗的有效性进行评估。在过去的八年中，我们参与了在戴维森县纳什维尔（人口578,698）对患有急性呼吸道疾病的幼儿进行的基于人群的流感监测，这是疾病预防控制中心新疫苗监测网络的一部分。在美国国立卫生研究院疫苗治疗和评估股的两年支持下，我们在2006- 2007年流感季节期间对50岁至50岁的成年人启动了类似的监测，该监测将持续到2007- 2008年流感季节。我们的经验使我们有资格有效地开展对疫苗有效性进行年度评估所需的监测活动。我们与戴维森县医院建立了合作关系，这些医院为住院治疗急性呼吸道疾病的95%的县儿童和50%的县成人提供护理。已经建立了纳入和检测合格患者的程序，制定了数据收集表格并进行了实地测试，并改进和验证了实验室程序。我们建议对实验室确诊的成人和儿童流感进行积极的基于人群的监测，以确定该县流感相关住院和急诊就诊的年龄特异性比率。我们将与疾病预防控制中心和其他合作协议参与者合作，每年两次评估流感疫苗的有效性，一次在流感季节中期，一次在流感季节结束时。我们建议采用匹配病例对照分析来评估疫苗的有效性。研究对象将是一个系统的样本，包括因急性呼吸道疾病住院或急诊室就诊的6个月或以上的县儿童和成人。报名的受试者将提供鼻咽拭子在研究实验室进行流感测试。受试者或其父母/监护人将提供有关其急性疾病、病史和流感疫苗接种状况的信息。病例将通过逆转录酶-聚合酶链反应（RT-PCR）或病毒培养检测流感病毒来确定。所有通过RT-PCR和培养检测流感呈阴性的研究对象都有资格作为对照。在第一年，我们还将收集、处理、储存并运送到疾病预防控制中心，450对血清和150对外周血单个核细胞样本，以评估50岁至50岁成人对流感疫苗的体液和细胞免疫反应。