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.

项目摘要摘要-强制性核心 强制性核心组件 A 的目的是支持美国的增强监控网络 儿科机构制定和实施标准研究方案，以开展前瞻性积极研究 在规定的住院和急诊科 (ED) 环境中进行基于人群的监测：a) 急性 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) 由呼吸道病毒引起，包括流感、RSV、副流感病毒、人类偏肺病毒、 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 儿科患者在这些儿科医疗机构寻求医疗保健。该计划的结果将 用于提供疫苗建议并评估美国轮状病毒、流感对公共卫生的影响 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 治疗方法和疫苗正在开发中。强制性核心组件 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 在儿科住院和急诊室设置中，并在汉密尔顿县 <18 岁儿童中招募无症状健康对照 岁数。通过我们已经建立的 ARI、AGE 和 HC 监控平台，我们将 1) 执行 积极监测以确定住院患者和急诊科急性病毒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) 描述感染的临床和流行病学因素，包括 无症状儿童和 3) 评估 VE 以及疫苗和其他现有或预计干预措施的影响 在研究协议期间使用测试提供轮状病毒和流感疫苗 RSV 和 SARS-CoV-2 的阴性设计（如有）并推荐用于儿童和 青少年。对于目标 2，我们将开展急性弛缓性脊髓炎（AFM in <18 岁的住院儿童）。通过我们已经建立的 AFM 监控平台，我们将 1) 通过与我们的合作积极寻找病例，确定我们儿科机构的 AFM 基线率 神经病学和神经放射学联合研究人员使用 CDC 的病例定义来满足临床症状的患者 AFM 和脊髓 MRI 的标准显示，通过进行积极的治疗，至少有一些灰质受累 监测并确定我们辖区内住院儿童的 AFM 事件率，2) 将 AFM 发生率与我们所在地人群中循环呼吸道和肠道病原体的发生率进行比较 - 基于主动监测计划和 3) 描述儿科 AFM 的临床谱并与 其他类似神经系统疾病的临床谱。

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