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

项目摘要-强制核心 强制性核心组件A的目的是支持美国的增强型监视网络 儿科机构制定和实施标准的研究方案，以进行前瞻性的积极 在规定的住院和急诊科（艾德）环境中进行基于人群的监测，用于a）急性 由诺如病毒、轮状病毒和其他肠道病原体引起的胃肠炎（AGE），B）急性呼吸道感染 (ARI)由于呼吸道病毒包括流感病毒、RSV、副流感病毒、人偏肺病毒， 鼻病毒、肠道病毒（包括EV-D 68）、腺病毒、冠状病毒（包括SARS-CoV-2）和 其他呼吸道病毒，c）和健康对照（HC）和d）急性弛缓性肌麻痹（AFM）综合征， 在这些儿科医疗机构寻求医疗保健的儿科患者。该计划的结果将 用于提供疫苗建议和评估美国轮状病毒、流感 和SARS-CoV-2疫苗接种计划，并提供其他传染病的流行病学数据， 治疗和疫苗的发展。强制性核心组成部分A有两个目标： 对于目标1，我们将对呼吸道和肠道病毒病原体进行基于人群的主动监测 在儿科住院和艾德环境中，并在汉密尔顿公司<18岁儿童中招募无症状健康对照 岁的通过我们已经建立的ARI、AGE和HC监控平台，我们将1）执行 主动监测以确定住院和艾德急性病毒性肠道和呼吸道疾病的病因和负担 我们定义的人群中的疾病，2）表征感染的临床和流行病学因素，包括 无症状儿童和3）评估VE和疫苗的影响以及其他可用或计划的干预措施 在轮状病毒和流感疫苗的研究协议期内， 阴性设计，适用于RSV和SARS-CoV-2（如适用），并推荐用于儿童， 青少年。对于目标2，我们将对急性弛缓性肌麻痹症（AFM）进行监测活动， 18岁以下住院儿童）。通过我们已经建立的AFM监控平台，我们将1） 通过积极的病例发现，与我们的儿科机构合作，确定AFM的基线率。 神经病学和神经放射学合作研究者使用CDC对符合临床 标准AFM和脊髓MRI显示至少有一些灰质参与传导活性 监测和建立我们的集水区内住院儿童中AFM的发病率，2） 将AFM的比率与我们研究中心的循环呼吸道和肠道病原体的比率进行比较- 基于主动监测程序和3）表征儿科AFM的临床谱，并与 其他类似神经系统疾病的临床表现。

PROJECT SUMMARY ABSTRACT- MANDATORY CORE The purpose for Mandatory Core Component A is to support an Enhanced Surveillance Network of US pediatric institutions to develop and implement standard research protocols to conduct prospective active population-based surveillance in defined inpatient and emergency department (ED) settings for a) acute gastroenteritis (AGE) due to norovirus, rotavirus and other enteric pathogens, b) acute respiratory infection (ARI) due to respiratory viruses including influenza, RSV, parainfluenza viruses, human metapneumovirus, rhinoviruses, enteroviruses (including EV-D68), adenoviruses, coronaviruses (including SARS-CoV-2) and other respiratory viruses, c) and healthy controls (HC) and d) Acute Flaccid Myelitis (AFM) syndrome among pediatric patients seeking healthcare at these pediatric medical institutions. The results from this program will be used to inform vaccine recommendations and assess the public health impact of the US rotavirus, influenza and SARS-CoV-2 vaccination programs and provide epidemiologic data for other infectious diseases with therapeutics and vaccines in development. There are two objectives for Mandatory Core Component A:: For Objective 1 we will conduct population-based active surveillance for respiratory and enteric viral pathogens in pediatric inpatient and ED settings and enroll asymptomatic healthy controls in Hamilton Co. children <18 years of age. Through our already established ARI, AGE and HC Surveillance Platforms we will 1) perform active surveillance to determine the etiology and burden of inpatient and ED acute viral enteric and respiratory diseases in our defined population, 2) characterize the clinical and epidemiologic factors of infections including asymptomatic children and 3) evaluate VE and impact of vaccines and other interventions available or projected to become available during the study agreement period for rotavirus and influenza vaccines using a test- negative design and for RSV and SARS-CoV-2, when available and recommended for children and adolescents. For Objective 2 we will conduct surveillance activities for acute flaccid myelitis (AFM in hospitalized children <18 years of age). Through our already established AFM Surveillance Platform, we will 1) define baseline rates of AFM in our pediatric institution through active case finding in collaboration with our Neurology and Neuroradiology Co-Investigators using the CDC's case definition for patients meeting the clinical criterion for AFM and a spinal MRI showing at least some gray matter involvement by conducting active surveillance and establishing incident rates for AFM among hospitalized children within our catchment area, 2) compare rates of AFM to rates of circulating respiratory and enteric pathogens at our site from our population- based active surveillance program and 3) characterize the clinical spectrum of pediatric AFM and compare with the clinical spectrum seen with other similar neurologic conditions.