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

IP21-002，美国增强监测网络，评估预防儿童肠道和呼吸道病毒的疫苗负担、自然史和有效性

• 批准号: 10472401
• 负责人: Jennifer E Schuster
• 金额: $ 193.6万
• 依托单位: CHILDREN'S MERCY HOSP (KANSAS CITY, MO)
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10472401
• 关键词: IP21; 002; US; Enhanced; Surveillance

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.

A 部分：项目摘要 堪萨斯城新疫苗监测网络 (KC-NVSN) 计划一直在执行 基于人群、经实验室确认的急性胃肠炎 (AGE) 疾病主动监测 和急性呼吸道疾病 (ARI) 在堪萨斯州儿童慈善中心 (CM) 寻求护理的儿童 分别自 2009 年和 2015 年起在密苏里州 (KC) 市。 在当前的提案中，KC-NVSN 计划寻求继续现有的儿科 AGE 和 将儿科 ARI 监测范围扩大到堪萨斯城大都市区的六个县，针对以下儿童中出现的儿童 CM 的住院和急诊科 (ED) 设置与年龄和时间匹配的健康控制。 在门诊寻求良好儿童护理的儿童也将被纳入我们将纳入符合资格的儿童。 儿童（如提案中所定义）经许可访问或入住我们的医院系统 注册后，我们将获得 CM 机构审查委员会 (IRB) 批准的同意书。 采访家长，收集电子病历图表数据，并检索流感收据的纸质副本和 轮状病毒 (RV) 疫苗，以及任何未来的疫苗（SARS-CoV-2、RSV、NoV）。 检测 RV、诺如病毒 (NoV) 和其他胃肠道病原体以及呼吸道样本 23 呼吸道病原体，例如流感（类型和特定亚型）和其他非流感 我们将使用前瞻性监测来进行急性病毒感染。 弛缓性脊髓炎 (AFM) 描述了 KC-NVSN 的临床疾病谱和负担率。 数据将提供基于人口的估计，以实现以下具体目标： 1. 评估入组儿童的AGE和ARI病原体负担。 2. 为了评估疫苗对 RV 引起的医疗疾病的有效性 (VE)， 流感，以及即将通过在登记儿童中进行实验室确认测试的疫苗。 3. 评估 AFM 临床谱和负担以及与 ARI 和 AGE 疾病的关联。 KC-NVSN 计划数据将与其他地理位置不同站点的数据相结合，以 估计社区获得性 AGE 和 ARI 的全国发病率、负担和病因学， 用于轮状病毒和季节性流感疫苗接种的 VE 该网络还将解决一些问题。 与儿科传染病自然史相关的重要科学问题， 传播动态、疫苗对目标人群和弱势人群的影响以及因素 VE.来自该网络的监测数据将提供及时且高度的信息。 为公共卫生措施和儿科疫苗相关政策提供有用数据，旨在 控制美国儿童的 AGE 和 ARI。