Mandatory_Estimates of Vaccine Effectiveness Against Medically-Attended, PCR-Confirmed Influenza in West South Central U.S.

流感病毒在不断进化，导致每隔一段时间就选择疫苗株进行重新配制。 赛季流感疫苗在预防流感相关发病率方面的有效性（VE）的年度估计值如下： 这对评估年度全国疫苗接种计划提供的保护至关重要。我们的长期目标 是为了提高对病毒性呼吸道感染流行病学的理解，同时测量公众 免疫接种对减少总的疾病负担和改善 人口我们计划根据CDC ACIP建议的年度报告， Baylor Scott &白色健康中心（BSWCTX）患者的普遍免疫策略 人口目的是为登记的人群获得可靠的疫苗接种信息， 准确估计年度VE，以预防流感相关的急性呼吸道疾病 （MAARI）在疫苗年龄合格人群中。我们的核心假设是及时有效地 测量年度VE和季节性/大流行性流感、RSV和其他 呼吸道病毒是可持续的。基本原理是，通过评估赛季中期的VE，ACIP可以建议 根据需要，对高危人群进行抗病毒化学预防和治疗。为实现总体目标， 将追求以下具体目标：1）针对实验室确认的流感评估流感VE 在至少1，000名儿童和成人中，包括三个年龄组中的每一个年龄组至少333人（6 月- 17岁、18-49岁和≥50岁），在5个季节的每个季节期间， 从2016年至2017年，6个月至8岁的幼儿中至少有100人， 年龄≥65岁的成人。2)评估季节性流感造成的疾病负担（从 2016-17），RSV和其他呼吸道病毒（在第3-5季）在儿童（6个月- 17岁）中， 成人（年龄18-64岁）和老年人（年龄≥65岁）。3)发展流感大流行防备工作 操作计划和试点研究方法（在第3-5季），以描述新的流行病学 流感病毒感染，每当下一次流感大流行即将在世界任何地方发生时开始， 估计MAARI大流行性流感发病率，估计季节性和大流行性流感疫苗的VE 用于预防大流行性流感相关MAARI，并评估抗病毒药物的使用和有效性 用于治疗大流行性流感的药剂。为了实现这些目标，我们将估计 使用阴性试验设计，在门诊环境中招募的人群中， BSWCTX来源人群中的季节性/大流行性流感、RSV和其他呼吸道病毒，以及 检查与VE相关的因素。拟议的研究是创新的，因为它将产生新的知识 在用于适当测量不同医疗保健环境中的流感VE和测量 美国西南中部地区的流感、RSV和其他呼吸道病毒疾病

Influenza viruses are constantly evolving, resulting in vaccine strains being selected for reformulation every season. Annual estimates of influenza vaccine effectiveness (VE) in preventing influenza-related morbidity are essential in evaluating the protection provided by annual, nationwide vaccination programs. Our long-term goal is to advance the understanding of the epidemiology of viral respiratory infections while measuring the public health impact of immunization on reducing the overall burden of illness and on improving the health of the population. We plan to systematically evaluate the influenza VE with the CDC ACIP recommended annual universal immunization strategy in the Baylor Scott & White Health, Central Texas (BSWCTX) patient population. The objective is to obtain reliable vaccination information for the enrolled population and provide accurate estimates of annual VE to prevent influenza-associated medically-attended acute respiratory illness (MAARI) in the vaccine age-eligible population. Our central hypothesis is that timely and efficient measurement of annual VE and burden of illness due to seasonal/pandemic influenza, RSV and other respiratory viruses is sustainable. The rationale is that by assessing the mid-season VE, ACIP can recommend antiviral chemoprophylaxis and treatment for high risk groups, as needed. To accomplish the overall objective, the following specific aims will be pursued: 1) Assess influenza VE against laboratory-confirmed influenza among at least 1,000 children and adults, including at least 333 persons from each of three age groups (6 months – 17 years, 18-49 years and ≥50 years) with MAARI in ambulatory settings during each of 5 seasons from 2016-17, with at least 100 among young children aged 6 months – 8 years and with at least 100 among adults aged ≥65 years. 2) Evaluate disease burden due to seasonal influenza (during each of 5 seasons from 2016-17), RSV and other respiratory viruses (during seasons 3-5) among children (ages 6 months – 17 years), adults (ages 18-64 years) and older adults (ages ≥65 years). 3) Develop influenza pandemic preparedness operational plan and pilot research methods (during seasons 3-5) to describe the epidemiology of the novel influenza virus infection, beginning whenever the next influenza pandemic is imminent anywhere in the world, estimate MAARI incidence of pandemic influenza, estimate VE of seasonal and pandemic influenza vaccines for prevention of pandemic influenza-associated MAARI, and evaluate the use and effectiveness of antiviral agents for treatment of pandemic influenza. To accomplish these goals, we will estimate real-time VE for the enrolled population in the ambulatory setting using a test-negative design, estimate burden of illness of seasonal/pandemic influenza, RSV and other respiratory viruses in the BSWCTX source population, and examine factors associated with VE. The proposed research is innovative in that it will generate new knowledge in the methods used to aptly measure influenza VE in different healthcare settings and measure burden of illness of influenza, RSV and other respiratory viruses in the West South Central region of the U.S.