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: 10669091
• 负责人: MARY A STAAT
• 金额: $ 275万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 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/10669091
• 关键词: IP21; 002; US; Enhanced; Surveillance

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.

项目摘要抽象 - 强制性核心 强制性核心组件A的目的是支持我们增强的监视网络 儿科机构开发和实施标准研究方案，以进行潜在的活动 在定义的住院和急诊室（ED）设置的基于人群的监视a）急性 由于诺如病毒，轮状病毒和其他肠道病原体引起的胃肠炎（年龄），b）急性呼吸道感染 （ARI）由于呼吸道病毒，包括流感，RSV，Parainfluenza病毒，人元病毒， 鼻病毒，肠病毒（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）急性松弛脊髓炎（AFM）综合征 在这些小儿医疗机构寻求医疗保健的儿科患者。该程序的结果将 用于为疫苗建议提供信息，并评估美国轮状病毒的公共卫生影响 和SARS-COV-2疫苗接种计划，并为其他传染病提供流行病学数据 开发中的治疗和疫苗。强制性核心组件A ::有两个目标 对于目标1，我们将进行基于人群的主动监测呼吸道和肠病毒病原体 在小儿住院和ED设置以及汉密尔顿公司的无症状健康对照组中。儿童<18 年龄。通过我们已经建立的ARI，年龄和HC监视平台，我们将进行1） 主动监视以确定住院和急性病毒肠和呼吸道的病因和负担 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）评估疫苗和其他可用干预措施的VE和影响 在研究协议期间用于轮状病毒和流感疫苗的研究期间可用 负面设计以及RSV和SARS-COV-2，如果可用并建议儿童和建议 青少年。对于目标2，我们将进行急性松弛性脊髓炎的监视活动（AFM 住院的儿童<18岁）。通过我们已经建立的AFM监视平台，我们将1） 通过与我们的活跃病例发现，在我们的儿科机构中定义AFM的基线率 神经病学和神经放射学的共同研究剂使用CDC的病例定义为患者符合临床的患者 AFM和脊柱MRI的标准至少通过进行主动来显示至少一些灰质参与 在我们的集水区内住院儿童中的AFM的监视和建立事件率，2） 将AFM的发生率与我们人群中我们网站循环呼吸道和肠道病原体的率进行比较 - 基于主动监视计划和3）特征是小儿AFM的临床光谱 在其他类似的神经系统条件下可见的临床光谱。

项目成果

Respiratory Virus Surveillance Among Children with Acute Respiratory Illnesses - New Vaccine Surveillance Network, United States, 2016-2021.

• DOI: 10.15585/mmwr.mm7140a1
• 发表时间: 2022-10-07
• 期刊: MMWR. Morbidity and mortality weekly report

Sustained Within-season Vaccine Effectiveness Against Influenza-associated Hospitalization in Children: Evidence From the New Vaccine Surveillance Network, 2015-2016 Through 2019-2020.

季节性疫苗对儿童流感相关住院治疗的持续有效性：来自 2015-2016 年至 2019-2020 年新疫苗监测网络的证据。

• DOI: 10.1093/cid/ciac577
• 发表时间: 2023
• 期刊: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
• 作者: Sahni,LeilaC;Naioti,EricA;Olson,SamanthaM;Campbell,AngelaP;Michaels,MarianG;Williams,JohnV;Staat,MaryAllen;Schlaudecker,ElizabethP;McNeal,MonicaM;Halasa,NatashaB;Stewart,LauraS;Chappell,JamesD;Englund,JanetA;Klein,E
• 通讯作者: Klein,E