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

• 批准号: 8507010
• 负责人: EDWARD BELONGIA
• 金额: $ 108.5万
• 依托单位: MARSHFIELD CLINIC RESEARCH FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8507010
• 关键词: Core_plus; Option_B_C_Influenza; Vaccine; Effectiveness; Wisconsin

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 流感是发病和死亡的重要原因，接种流感疫苗是关键 预防流感的组成部分。与许多其他感染不同，流感病毒是 疫苗成分不断进化，并根据这些变化进行修改。作为 因此，流感疫苗的有效性每年都不一样， 亚型抗原匹配和年龄组疫苗临床有效性年度评估 需要评估国家疫苗建议和政策的影响， 病毒抗原性变化与临床保护的关系， 大流行期间的疫苗评估。疫苗有效性的中期估计 对公共卫生机构和医生都很有用。为了评估疫苗的有效性，患者 患有急性呼吸道疾病（发热、发热或咳嗽）的患者将从预定义的 流感季节的人群队列。登记将在 门诊、紧急护理或急诊科就诊。大多数注册将发生在 但有些患者将通过电话联系，并在 在被诊断为急性呼吸道疾病后的第二天。在获得知情同意后， 将使用核酸扩增试验检测鼻和咽喉拭子中的甲型和B型流感病毒 （RT-PCR）。将对阳性进行病毒培养，并将一个子集发送给CDC， 抗原特性流感免疫状态将由经过验证的 免疫登记处。将使用病例对照方法计算疫苗有效性 其中病例包括RT-PCR确认的流感受试者，对照包括研究 非流感性呼吸道疾病的参与者（阴性RT-PCR）。将评估严重度 通过获取住院和X光确诊肺炎事件的数据。数据将 提供给CDC与其他参与研究中心进行综合分析，包括季中数据 进行有效性的中期分析。对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。 我们将在接种疫苗的人群中估计有医疗护理的流感的基于人群的发病率。 和未接种疫苗的人。拟议的研究将1）生成数据以支持和 告知医生实践和公共卫生机构关于预防流感建议， 2)提高我们对抗原距离及其与临床疫苗关系的认识 有效性，以及3）提供测量VE和研究流感流行病学的平台 在大流行期间。