Core_plus Option_B_C_Influenza Vaccine Effectiveness in a Wisconsin Population

Core_plus Option_B_C_流感疫苗在威斯康星州人群中的有效性

基本信息

批准号：
8874756
负责人：
EDWARD BELONGIA
金额：
$ 110.76万
依托单位：
MARSHFIELD CLINIC RESEARCH FOUNDATION
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-07-01 至 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8874756
关键词：
Core_plus Option_B_C_Influenza Vaccine Effectiveness Wisconsin

项目摘要

PROJECT SUMMARY Influenza is an important cause of morbidity and mortality, and influenza vaccination is a key component of influenza prevention. Unlike many other infections, influenza viruses are constantly evolving and the vaccine components are modified to account for these changes. As a result, the effectiveness of influenza vaccine varies from year to year, and it can vary by subtype, antigenic match, and age group. Annual assessment of clinical vaccine effectiveness is needed to evaluate the impact of national 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. To estimate vaccine effectiveness, patients with acute respiratory illness (fever, feverishness or cough) will be enrolled from a predefined population cohort during the influenza season. Enrollment will occur during or after an outpatient, urgent care or emergency department encounter. Most enrollments will occur at the point of care, but some patients will be contacted by phone and screened for eligibility on the day after receiving a diagnosis for acute respiratory illness. After obtaining informed consent, nose and throat swabs will be tested for influenza A and B using a nucleic acid amplification test (RT-PCR). Viral cultures will be performed on positives, and a subset will be sent to CDC for antigenic characterization. Influenza immunization status will be determined by a validated immunization registry. Vaccine effectiveness will be calculated using a case control approach where cases include participants with RT-PCR confirmed influenza and controls include study participants with noninfluenza respiratory illness (negative RT-PCR). Severity will be assessed by obtaining data on hospital admissions and x-ray confirmed pneumonia episodes. Data will provided to CDC for combined analyses with other participating sites, including mid-season data for interim analysis of effectiveness. Separate estimates of vaccine effectiveness will be calculated for different age groups, for each influenza type/subtype, and for high risk individuals. We will estimate the population-based attack rate for medically attended influenza in vaccinated and unvaccinated individuals. The proposed research will 1) generate data to support and inform physician practice and public health agency recommendations for influenza prevention, 2) increase our understanding of antigenic distance and its relationship to clinical vaccine effectiveness, and 3) provide a platform to measure VE and study the epidemiology of influenza during a pandemic.

项目概要流感是导致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。与许多其他感染不同，流感病毒不断发展，疫苗成分也不断修改以适应这些变化。作为因此，流感疫苗的有效性每年都会有所不同，而且会因年份而异。亚型、抗原匹配和年龄组。临床疫苗有效性年度评估需要评估国家疫苗建议和政策的影响，了解病毒抗原变化与临床保护的关系，为应对大流行期间的疫苗评估。疫苗有效性的中期、中期估计对公共卫生机构和医生有用。为了估计疫苗的有效性，患者患有急性呼吸道疾病（发烧、发烧或咳嗽）的患者将从预定的时间入组流感季节期间的人口队列。注册将在考试期间或之后进行门诊、紧急护理或急诊室遇到的情况。大多数注册将在护理点，但我们将通过电话联系一些患者并在现场筛选其资格收到急性呼吸道疾病诊断后的第二天。获得知情同意后，将使用核酸扩增测试对鼻子和喉咙拭子进行甲型和乙型流感病毒检测 (RT-PCR)。将对阳性结果进行病毒培养，并将一部分送往 CDC 进行检测抗原表征。流感免疫状态将由经过验证的免疫登记处。疫苗有效性将使用病例对照方法计算其中病例包括 RT-PCR 确诊流感的参与者，对照包括研究患有非流感呼吸道疾病的参与者（RT-PCR 阴性）。将评估严重程度通过获取入院数据和 X 射线确诊的肺炎发作数据。数据会提供给 CDC 与其他参与站点进行综合分析，包括季中数据用于有效性的中期分析。疫苗有效性的单独估计将针对不同年龄组、每种流感类型/亚型以及高风险个体进行计算。我们将估计接种疫苗后就医的流感的人群发病率以及未接种疫苗的个人。拟议的研究将 1）生成数据来支持和告知医生实践和公共卫生机构关于流感预防的建议， 2）增加我们对抗原距离及其与临床疫苗关系的理解有效性，3) 提供测量 VE 和研究流感流行病学的平台大流行期间。