IP21-002, US Enhanced Surveillance Network to Assess Burden, Natural History, and Effectiveness of Vaccines to Prevent Enteric and Respiratory Viruses in Children

构成部分A：项目摘要 堪萨斯市-新疫苗监测网络（KC-NVSN）计划一直在执行 以人群为基础，经实验室确认的急性胃肠炎（AGE）疾病的主动监测 在堪萨斯的儿童慈善机构（CM）寻求治疗的儿童中， 自2009年和2015年以来，分别在密苏里州的城市（KC）。 在目前的提案中，KC-NVSN计划旨在继续现有的儿科AGE， 将儿科ARI监测扩大到六个县的KC大都市区， CM的住院部和急诊部（艾德）设置。年龄和时间匹配的健康对照 在门诊寻求良好儿童护理的儿童也将参加。我们将招收符合条件的学生 使用许可访问或入住我们医院系统的儿童（如提案中所定义） 以及CM机构审查委员会（IRB）批准的同意书。注册后，我们将 访问家长，收集EMR图表数据，并检索流感收据的硬拷贝， 轮状病毒（RV）疫苗和任何未来的疫苗（SARS-CoV-2、RSV、NoV）。粪便标本将 检测RV、诺如病毒（NoV）和其他GI病原体，以及23份呼吸道标本 呼吸道病原体，例如，流感（类型和特定亚型）和其他非流感 病毒（RSV、EV-D 68和SARS-CoV-2等）。我们将使用前瞻性监测急性 弛缓性肌无力（AFM）表征临床疾病谱和负担率。KC-NVSN 数据将提供基于人口的估计数，以实现以下具体目标： 1.评估入组儿童中AGE和ARI病原体的负担。 2.为了评估疫苗对RV引起的医疗护理疾病的有效性（VE）， 流感，以及即将通过实验室确认的测试在登记的儿童中接种疫苗。 3.评估AFM临床谱和负担以及与ARI和AGE疾病的相关性。 KC-NVSN计划数据将与其他地理位置不同的站点数据相结合， 估计社区获得性AGE和ARI的全国发病率、负担和病因， VE用于轮状病毒和季节性流感疫苗接种。该网络还将解决几个 与儿科感染性疾病自然史相关的重要科学问题， 传播动态、疫苗对目标人群和脆弱人群的影响以及影响因素 影响VE。该网络产生的监测数据将提供及时和高度 为公共卫生措施和儿科疫苗相关政策提供信息的有用数据， 控制美国儿童的年龄和ARI。

Component A: Project Summary The Kansas City-New Vaccine Surveillance Network (KC-NVSN) program has been performing population-based, laboratory-confirmed, active surveillance of acute gastroenteritis (AGE) illness and acute respiratory illness (ARI) in children seeking care at Children’s Mercy (CM), in Kansas City (KC), MO since 2009 and 2015, respectively. In the current proposal, the KC-NVSN program seeks to continue the existing pediatric AGE and expand the pediatric ARI surveillance to the six county KC metropolitan area for children seen in CM’s inpatient and emergency department (ED) settings. Age- and time-matched healthy control children seeking well-child care in the outpatient setting will also be enrolled. We will enroll eligible children (as defined in the proposal) visiting or admitted to our hospital system using permission and assent forms approved by CM’s institutional review board (IRB). After enrollment, we will interview parents, collect EMR chart data, and retrieve hard copies of receipt of influenza and rotavirus (RV) vaccine, and any future vaccines (SARS-CoV-2, RSV, NoV). Stool specimens will be tested for RV, norovirus (NoV), and other GI pathogens, and respiratory specimens for 23 respiratory pathogens, e.g., influenza (types and specific subtypes) and other non-influenza viruses (RSV, EV-D68, and SARS-CoV-2, etc). We will use prospective surveillance for acute flaccid myelitis (AFM) characterizing the clinical disease spectrum and burden rates. KC-NVSN data will provide population-based estimates to address the following specific aims: 1. To assess the burden of AGE and ARI pathogens among enrolled children. 2. To assess vaccine effectiveness (VE) against medically attended illness due to RV, influenza, and upcoming vaccines via laboratory-confirmed testing among enrolled children. 3. To assess AFM clinical spectra and burden and associations with ARI and AGE illnesses. The KC-NVSN program data will be combined with other geographically diverse sites’ data to estimate the national incidence, burden, and etiology of community-acquired AGE and ARI and VE for rotavirus and seasonal influenza vaccinations. This network will also address several important scientific questions related to the natural history of pediatric infectious diseases, transmission dynamics, impact of vaccine on targeted and vulnerable populations, and factors influencing VE. The surveillance data generated from this network will provide timely and highly useful data to inform public health measures and pediatric vaccine-related policies aimed at controlling AGE and ARI in US children.