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

项目摘要摘要--强制性核心 强制性核心组件A的目的是支持美国增强的监视网络 儿科机构制定和实施标准研究方案以进行前瞻性的积极研究 在确定的住院和急诊科(ED)环境中进行以人群为基础的监测 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、RSV、副流感病毒、人偏肺病毒、 鼻病毒、肠道病毒(包括EV-D68)、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)急性弛缓性脊髓炎(AFM)综合征 在这些儿科医疗机构寻求医疗保健的儿科患者。这项计划的结果将是 用于为疫苗推荐提供信息，并评估美国轮状病毒流感对公共健康的影响 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 治疗学和疫苗正在开发中。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以人群为基础的积极监测。 在儿科住院患者和ED环境中，并在汉密尔顿公司的儿童和18；中登记无症状的健康对照 几年前。通过我们已经建立的ARI、AGE和HC监控平台，我们将1)执行 主动监测确定住院和急诊急性病毒性肠病和呼吸系统疾病的病原学和负担 我们定义的人群中的疾病，2)感染的临床和流行病学因素包括 无症状儿童和3)评估VE和疫苗及其他现有或计划干预措施的影响 在研究协议期内使用以下测试获得轮状病毒和流感疫苗- 阴性设计和RSV和SARS-CoV-2，当可用并推荐给儿童和 青少年。对于目标2，我们将开展急性弛缓性脊髓炎(AFM)监测活动 住院儿童(18岁)。通过我们已经建立的AFM监视平台，我们将1) 通过与我们的合作，通过积极的病例发现，确定我们儿科机构的AFM基线比率 神经病学和神经放射学联合调查员使用疾控中心对符合临床要求的患者的病例定义 AFM和脊椎MRI显示至少部分灰质受累的标准 监测和建立我们流域内住院儿童AFM的发病率，2) 将AFM的比率与我们现场人群中循环的呼吸道和肠道病原体的比率进行比较- 3)儿童原子力显微镜的临床谱特征，并与 临床谱系可见于其他类似的神经疾病。

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.