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: 8232626
• 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/8232626
• 关键词: Core_plus; Option_B_C_Influenza; Vaccine; Effectiveness; Wisconsin

DESCRIPTION (provided by applicant): 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 non-influenza 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.

说明(申请人提供)：流感是导致发病和死亡的重要原因，接种流感疫苗是预防流感的关键组成部分。与许多其他感染不同，流感病毒不断进化，疫苗成分经过修改以适应这些变化。因此，流感疫苗的效果每年都不同，而且可能会因亚型、抗原匹配和年龄组而异。需要对临床疫苗效力进行年度评估，以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之间的关系，并为大流行期间的疫苗评估做准备。对疫苗效力的中期、中期评估对公共卫生机构和医生很有用。为了评估疫苗的有效性，将在流感季节从预先确定的人群队列中登记患有急性呼吸道疾病(发烧、发烧或咳嗽)的患者。登记将在门诊、紧急护理或急诊科遇到期间或之后进行。大多数登记将在护理地点进行，但一些患者将在收到急性呼吸道疾病诊断后的第二天通过电话联系并进行资格筛查。在获得知情同意后，将使用核酸扩增测试(RT-PCR)对鼻子和喉咙拭子进行甲型和乙型流感检测。将对阳性患者进行病毒培养，并将其子集送往疾控中心进行抗原性鉴定。流感免疫状态将由经过验证的免疫登记来确定。将采用病例对照方法计算疫苗效力，其中病例包括RT-PCR确诊的流感参与者，对照包括患有非流感呼吸道疾病(阴性RT-PCR)的研究参与者。严重程度将通过获得住院和X光确认的肺炎事件的数据进行评估。数据将提供给疾病预防控制中心，用于与其他参与地点的联合分析，包括用于中期有效性分析的季节中期数据。将分别计算不同年龄组、每种流感类型/亚型和高危个人的疫苗效力估计数。我们将估计接种疫苗和未接种疫苗的个人中有医疗护理的流感的基于人群的发病率。拟议的研究将1)产生数据，以支持和告知医生执业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有效性的关系的了解；3)提供一个在大流行期间测量VE和研究流感流行病学的平台。