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: 7567227
• 负责人: EDWARD BELONGIA
• 金额: $ 95.9万
• 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 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7567227
• 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）：需要进行年度评估，以评估流感疫苗的有效性（VE），以预防医疗护理，实验室确认的流感疾病。我们从2004-05赛季开始在威斯康辛州进行这些研究，我们打算继续这项工作。每个季节，我们将建立一个研究队列，根据年龄组或高风险医疗状况推荐接种流感疫苗的个人。流感疫苗接种状况将由所有公共和私人免疫服务提供者使用的基于互联网的实时免疫登记来确定。研究队列的成员将被积极招募，在急性呼吸道疾病住院或门诊治疗期间或之后进行流感检测，持续时间<8天。有发热、发冷或咳嗽症状的患者将符合条件。研究协调员将在初级保健诊所、紧急护理和住院病房中确定并招募符合条件的队列成员。在临床接触期间未接触的患者将在第二天使用电子诊断代码识别并招募。将使用细胞培养和RT-PCR对鼻咽拭子和鼻拭子进行甲型和乙型流感病毒检测。流感病例将被定义为急性呼吸道或发热性疾病，并通过培养或RT-PCR记录流感感染。流感病毒感染的估计值将计算为100 × （1 - RR），其中RR是对登记和检测的接种疫苗患者与未接种疫苗患者实验室确诊流感相对风险的度量。对于病例对照分析，对照组将包括流感培养阴性和RT-PCR结果阴性的入组患者（检测阴性对照）。RR将从泊松回归模型中导出，该模型具有稳健方差估计，以解释每个患者的多个登记。回归模型将根据高危状态、入组周数和年龄进行调整。在确认50例实验室确诊病例后，将对VE进行季中中期分析。最后的分析将包括6-59个月大的儿童、65岁的成年人和5 - 49岁的健康人的VE的单独估计。所有流感分离株将提交给CDC进行抗原鉴定，我们将在每个季节评估VE与抗原匹配的关系。为了满足RFP中的可选目标5，我们将招募一组年龄较大的非机构队列成员（65岁）进行分层随机抽样，在接种疫苗前和接种疫苗后3至6周采集血液样本。配对的血清和pbmc将提供给疾病预防控制中心或指定的参考实验室，用于抗体滴度和细胞介导免疫的测量。