Rapid Estimation of Influenza Vaccine Effectiveness in a Wisconsin Population Coh

快速估计流感疫苗在威斯康星州人群中的有效性

• 批准号: 7905772
• 负责人: EDWARD BELONGIA
• 金额: $ 135万
• 依托单位: MARSHFIELD CLINIC RESEARCH FOUNDATION
• 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 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7905772
• 关键词: Rapid; Estimation; Influenza; Vaccine; Effectiveness

DESCRIPTION (provided by applicant): Annual assessments are needed to estimate influenza vaccine effectiveness (VE) for preventing medically-attended, laboratory-confirmed influenza illness. We have conducted these studies in Wisconsin since the 2004-05 season, and we propose to continue this work. Each season, we will establish a study cohort of individuals who are recommended to receive influenza vaccination based on age group or high risk medical condition. Influenza vaccination status will be determined by a real-time, internet-based immunization registry used by all public and private immunization providers serving the population. Members of the study cohort will be actively recruited for influenza testing during or after an inpatient or outpatient medical encounter for acute respiratory illness of <8 days duration. Patients with symptoms of feverishness, chills, or cough will be eligible. Research coordinators will identify and recruit eligible cohort members in primary care clinics, urgent care, and inpatient hospital wards. Ill patients who are not approached during a clinical encounter will be identified on the following day using electronic diagnosis codes and recruited. Nasopharyngeal and nasal swabs will be tested for influenza A and B virus using cell culture and RT-PCR. A case of influenza will be defined as an acute respiratory or febrile illness with documentation of influenza infection by culture or RT-PCR. Estimates of VE will be computed as 100 x (1 - RR), where RR is a measure of the relative risk of laboratory-confirmed influenza in the vaccinated versus unvaccinated patients who are enrolled and tested. For the case-control analysis, controls will include enrolled patients with a negative influenza culture and RT-PCR result (test-negative controls). RR will be derived from a Poisson regression model with robust variance estimation to account for multiple enrollments per patient. The regression models will adjust for high risk status, week of enrollment, and age. A mid-season interim analysis of VE will be performed after 50 laboratory- confirmed cases have been identified. The final analyses will include separate estimates of VE for children 6-59 months old, adults 65 years old, and healthy individuals 5 to 49 years old. All influenza isolates will be submitted to CDC for antigenic characterization, and we will assess the relationship between VE and antigenic match each season. To meet optional Objective 5 in the RFP, we will recruit a stratified random sample of elderly, non-institutionalized cohort members (65 years old) for collection of blood samples before vaccination and 3 to 6 weeks post-vaccination. Paired serum and PBMCs will be provided to CDC or a designated reference laboratory for antibody titers and measures of cell-mediated immunity.

描述（由申请人提供）：需要年度评估来估计流感疫苗有效性（VE），以防止医疗，实验室确认的流感疾病。自2004-05赛季以来，我们已经在威斯康星州进行了这些研究，我们建议继续这项工作。每个季节，我们都会建立一个研究队列，这些人被建议根据年龄组或高风险医疗状况接收流感疫苗接种。流感疫苗接种状况将取决于所有公共和私人免疫提供者为人口服务的实时，基于互联网的免疫注册中心。该研究队列的成员将在住院或门诊医疗遭遇急性呼吸道疾病期间或之后积极招募进行流感检查。有发烧，发冷或咳嗽的症状的患者符合条件。研究协调员将在初级保健诊所，紧急护理和住院医院病房中识别并招募合格的队列成员。第二天将使用电子诊断代码并招募临床遭遇期间未接触的患病患者。鼻咽和鼻拭子将使用细胞培养和RT-PCR测试流感和B病毒。流感病例将被定义为急性呼吸道或发热疾病，并记录了通过培养或RT-PCR感染流感的疾病。 VE的估计值将计算为100 X（1 -RR），其中RR是在接种疫苗和未接种疫苗的患者中的实验室确认流感的相对风险的量度。对于病例对照分析，对照组将包括具有阴性流感培养和RT-PCR结果（测试阴性对照）的招募患者。 RR将源自具有强大方差估计的泊松回归模型，以说明每个患者的多次入学率。回归模型将调整高风险状况，注册周和年龄。在确定了50例实验室确认病例后，将进行季节临界分析。最终分析将包括6-59个月大的儿童，65岁的成年人和5至49岁的健康个体的VE估计。所有流感分离株将提交给CDC进行抗原表征，我们将评估VE和抗原匹配之间的关系。为了满足RFP中的可选目标5，我们将招募一个分层的随机样本，以在疫苗接种前和疫苗接种后3至6周之前收集血液样本的老年人，非机构化的队列成员（65岁）。配对的血清和PBMC将提供给CDC或指定的参考实验室，以进行抗体滴度和细胞介导的免疫测量。