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.

项目摘要流感是发病率和死亡率的重要原因，流感疫苗是关键预防流感的组成部分。与许多其他感染不同，流感病毒是不断发展，修改了疫苗成分以解释这些变化。作为结果，流感疫苗的有效性每年都不同，它可能会有所不同亚型，抗原匹配和年龄组。临床疫苗有效性的年度评估需要评估国家疫苗建议和政策的影响，了解病毒和临床保护的抗原变化之间的关系，并为大流行期间的疫苗评估。疫苗有效性的临时，季节中期估计对公共卫生机构和医师有用。为了估计疫苗有效性，患者急性呼吸道疾病（发烧，发烧或咳嗽）将从预定义的流感季节的人口队列。入学率将在或之后发生门诊，紧急护理或急诊科的相遇。大多数注册将发生在护理点，但是有些患者将通过电话与某些患者联系，并筛选有资格在接受急性呼吸系统疾病的诊断后一天。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流感和B的测试（RT-PCR）。病毒培养将以阳性进行，并将子集发送给CDC 抗原特征。流感免疫状态将由经过验证的免疫注册表。疫苗有效性将使用案例控制方法计算案例包括带有RT-PCR确认流感和对照的参与者包括研究非influenza呼吸道疾病的参与者（RT-PCR负）。严重程度将被评估通过获取医院入院和X射线检查的数据证实了肺炎发作。数据将提供给CDC与其他参与网站的合并分析，包括季节中期数据用于临时有效性分析。疫苗有效性的单独估计值将是针对不同年龄组，每种流感类型/亚型以及高风险个体计算。我们将估计接受接种疫苗的医学上参加流感的基于人群的攻击率和未接种的人。拟议的研究将1）生成数据以支持和告知医师实践和公共卫生机构预防流感的建议， 2）增加我们对抗原距离及其与临床疫苗的关系 3）提供了一个平台来衡量VE和研究流感的流行病学在大流行期间。