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）：需要进行年度评估，以估计流感疫苗预防经医疗护理、实验室确认的流感疾病的有效性（VE）。我们从2004-05赛季开始就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受流感疫苗接种的个人。流感疫苗接种状况将由所有为人口服务的公共和私营免疫接种提供者使用的实时、基于互联网的免疫接种登记处确定。在因急性呼吸道疾病住院或门诊就诊期间或之后（持续时间<8天），将积极招募研究队列成员进行流感检测。有发热、寒战或咳嗽症状的患者将有资格参加研究。研究协调员将在初级保健诊所、紧急护理和住院病房确定和招募合格的队列成员。在临床就诊期间未接触的患病患者将在第二天使用电子诊断代码进行识别并招募。将使用细胞培养和RT-PCR检测鼻咽和鼻拭子中的甲型和B型流感病毒。流感病例将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。VE的估计值将计算为100 x（1 - RR），其中RR是入组和检测的接种疫苗患者与未接种疫苗患者中实验室确认流感的相对风险的指标。对于病例对照分析，对照将包括流感病毒培养和RT-PCR结果为阴性的入组患者（检测阴性对照）。RR将从具有稳健方差估计的Poisson回归模型推导，以解释每例患者的多次入组。回归模型将根据高风险状态、入组周数和年龄进行调整。在确定了50例实验室确诊病例后，将对VE进行季节中期分析。最终分析将包括6-59个月大的儿童、65岁的成人和5 - 49岁的健康个体的VE单独估计值。所有流感分离株将提交给CDC进行抗原表征，我们将评估每个季节VE和抗原匹配之间的关系。为了满足RFP中可选的目标5，我们将招募一批分层随机样本的老年、非机构队列成员（65岁），在疫苗接种前和疫苗接种后3至6周收集血液样本。将配对血清和PBMC提供给CDC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。