Core_Apt Measure of PCR-based Influenza Vaccine Effectiveness in Inpatient Adults

 描述(申请人提供)：流感病毒不断变化，需要每年重新配制疫苗。准确评估流感疫苗在预防流感感染方面的有效性，对于评估全国疫苗接种计划提供的保护至关重要。我们的长期目标是发现更先进的策略来衡量疫苗的有效性，潜在地减轻流感感染的总体负担。在斯科特和怀特纪念医院-坦普尔人口研究区(SWH-TPRA)成人来源人群中，将系统地调查采用ACIP推荐的普遍免疫策略的流感疫苗的有效性。拟议工作的目标是探索在成人住院患者(包括住院时间最长的老年人)中衡量针对实验室确认流感(VE-LCI)的疫苗有效性的策略。 费率。这包括确定、实施和评估创新、可行和 衡量急性住院环境中18岁或18岁以上人群VE-LCI的可持续战略。中心假设是，在美国，及时和有效地测量成人住院患者的VE-LCI是可行的和可持续的。这一假设将通过追求三个具体目标来检验：1)确定创新、可行和可持续的策略，以及时有效地测量18岁急性呼吸疾病(≥)住院患者的VE-LCI；2)实施上述策略来测量成人住院ARI患者的VE-LCI；以及3)评估上述策略来测量成人ARI患者的VE-LCI。为了实现这些目标，将对通过实时聚合酶链式反应(RT-PCR)检测出甲型和/或乙型流感呈阳性的因急性呼吸道感染入院的成人进行VE-LCI检测。在调整混杂因素后，将比较PCR确诊病例和年龄匹配的PCR阴性对照人群接种流感疫苗的几率。在2015-2016至2019-2020年间，300名因ARI入院的SWMH患者和800名成人将分别有资格参加BSWH CDC VE-LCI成人住院研究。采用试验阴性研究设计，对成人ARI住院患者的VE-LCI进行测量。将计算RT-PCR确诊病例和测试阴性对照的流感疫苗接种率，调整混杂因素的VE-LCI。这种方法是创新的，因为将确定增加流感疫苗接种对疾病负担的公共卫生影响的有效措施。拟议的研究具有重要意义，因为它将有助于更好地了解VE-LCI的及时和有效措施，这反过来将支持减少流感相关健康负担的目标。

 DESCRIPTION (provided by applicant): Influenza viruses are constantly changing, requiring the reformulation of vaccines every year. Accurately estimating influenza vaccine effectiveness in preventing influenza infection is critical in order to evaluate the protection provided by annua, nationwide vaccination programs. Our long-term goal is to discover more advanced strategies to measure vaccine effectiveness, to potentially reduce the overall burden of influenza infection. The effectiveness of influenza vaccines with the ACIP recommended universal immunization strategy in the Scott and White Memorial Hospital -Temple Population Research Area (SWH-TPRA) adult source population will be systematically investigated. The objective of the proposed work is to explore strategies for measuring vaccine effectiveness against lab-confirmed influenza (VE-LCI) in adult inpatients, including the elderly, who have the highest hospitalization rates. This includes the identification, implementation and evaluation of innovative, feasible, and sustainable strategies for measuring VE-LCI in persons aged 18 years or older in acute inpatient care settings. The central hypothesis is that timely and efficient measurement of VE- LCI in adult inpatients is feasible and sustainable in the U.S. This hypothesis will be tested by pursuing three specific aims: 1) Identify innovative, feasible, and sustainable strategies to measure VE-LCI in a timely and efficient manner for persons ≥ 18 years admitted with an acute respiratory illness (ARI) in acute inpatient care settings, 2) Implement the above strategies to measure VE-LCI for adult inpatients with ARI, and 3) Evaluate the above strategies to measure VE-LCI for adult inpatients with ARI. To achieve these goals, VE-LCI will be determined in adults admitted to SWMH with ARI who test positive for influenza A and/or B by the real-time polymerase chain reaction (RT-PCR) assay. The odds of being vaccinated against influenza for PCR-confirmed cases will be compared to age-matched PCR-negative controls, after adjusting for confounders. During 2015- 2016 through 2019-2020, 300 patients and 800 adults admitted to SWMH with an ARI will be eligible to participate in the BSWH CDC VE-LCI adult inpatient study, respectively. Using a test-negative study design, VE-LCI for adult inpatients with ARI will be measured. Influenza immunization rates will be calculated for the RT-PCR confirmed cases and test negative controls, adjusting VE-LCI for confounders. The approach is innovative because effective measures of the public health impact of increasing influenza immunization on burden of illness will be defined. The proposed research is significant, because it will support improved understanding of timely and efficient measures of VE-LCI, which in turn will support the goal of reducing influenza-associated health burdens.