IP21-002, New Vaccine Surveillance Network

摘要(针对组件A、B和C)。急性胃肠炎(AGE)和急性呼吸道疾病(ARI) 是儿童疾病的主要原因，在住院治疗中占很大比例，急诊 在美国，每年的部门(ED)就诊和门诊就诊。这些疾病是由不同的 病原体，包括流感、呼吸道合胞病毒、人类偏肺病毒、副流感病毒、 鼻病毒、肠病毒、冠状病毒包括SARS-CoV-2、腺病毒、轮状病毒、诺如病毒、星状病毒、 和萨普病毒。此外，这些病毒中的一些与其他新出现的儿童综合征有关， 包括与EV相关的急性弛缓性脊髓炎(AFM)和儿童的多系统炎症综合征 (mis-C)与SARS-CoV-2有关。因此，病毒年龄和急性呼吸道感染具有重大的公共卫生重要性，以及 对一些儿童造成严重的长期后果。几乎没有有效的抗病毒药物来治疗这些疾病。 病毒和疫苗接种是最有希望的干预措施。我们的目标是进行积极的，前瞻性的 以人口为基础的年龄和急性呼吸道感染监测；确定疫苗可预防疾病的负担； 描述临床特征、自然病史和种群动态；并确定疫苗的有效性 (V)对已批准和即将接种的疫苗进行监测，并随时间监测VE。新型疫苗监测网络 (NVSN)将促进这些目标。我们提出了四个具体目标： 目标1：对诺如病毒、轮状病毒和其他疾病引起的年龄进行前瞻性主动监测 在急诊室、住院和门诊就医的儿童中存在肠道病毒。 (A部分，强制性部分1；可选部分B) 目的2：对这些环境中呼吸道病毒引起的急性呼吸窘迫综合征进行前瞻性主动监测。 (A部分，强制性部分1；可选部分B) 目的3：在这些环境下对AFM综合征进行前瞻性主动监测。(A组分， 必填部分2) 目的4：开展管理信息系统-C前瞻性主动监测。(可选组件C) 匹兹堡分校在儿科临床研究方面拥有丰富的经验，包括作为NVSN的顶级注册机构 当前NVSN周期中的站点。匹兹堡大学儿童医院(CHP)的集水区面积为5.5 在周边的120万人口中，有95%的儿童住院治疗。因此， 环境对以人口为基础的研究来说是非常好的。经验丰富的调查小组包括专家 来自儿科传染病、重症护理、风湿病和心脏病学。收集的数据和样本 在这个项目中，将促进计算多个已获许可和正在进行的疫苗的VE的能力。结果是 将为诊断和治疗提供最佳做法，指导疫苗建议，以及 确定预防儿童因病毒性疾病就医的公共卫生干预措施。

SUMMARY (For Components A, B, and C). Acute gastroenteritis (AGE) and acute respiratory illness (ARI) are leading causes of childhood disease, accounting for a large proportion of hospitalizations, Emergency Department (ED) visits, and outpatient visits annually in the US. These illnesses are caused by diverse pathogens, including influenza, respiratory syncytial virus, human metapneumovirus, parainfluenza viruses, rhinovirus, enterovirus (EV), coronavirus including SARS-CoV-2, adenovirus, rotavirus, norovirus, astrovirus, and sapovirus. Moreover, some of these viruses are associated with other emerging childhood syndromes, including acute flaccid myelitis (AFM) associated with EV, and multisystem inflammatory syndrome in children (MIS-C) associated with SARS-CoV-2. Thus, viral AGE and ARI are of major public health importance, and result in serious long-term consequences for some children. There are few or no effective antivirals for these viruses and vaccination is the most promising intervention. Our goals are to conduct active, prospective population-based surveillance for AGE and ARI; to define the burden of vaccine-preventable diseases; describe the clinical features, natural history, and population dynamics; and establish vaccine effectiveness (VE) of licensed and impending vaccines and monitor VE over time. The New Vaccine Surveillance Network (NVSN) will facilitate these goals. We propose four Specific Aims: Aim 1: to conduct prospective active surveillance for AGE due to norovirus, rotavirus, and other enteric viruses among children seeking healthcare in ED, inpatient, and outpatient settings. (Component A, Mandatory Component 1; Optional Component B) Aim 2: to conduct prospective active surveillance for ARI due to respiratory viruses in these settings. (Component A, Mandatory Component 1; Optional Component B) Aim 3: to conduct prospective active surveillance for AFM syndrome in these settings. (Component A, Mandatory Component 2) Aim 4: to conduct prospective active surveillance for MIS-C. (Optional Component C) The Pittsburgh site has extensive experience with pediatric clinical research, including as a top enrolling NVSN site in the current NVSN cycle. UPMC Children’s Hospital of Pittsburgh (CHP) has a catchment area of >5.5 million people and admits >95% of hospitalized children in the surrounding county of >1.2 million. Thus, the environment is excellent for population-based research. The experienced investigative team includes experts from pediatric infectious diseases, critical care, rheumatology, and cardiology. The data and samples collected in this project will facilitate the capacity to calculate VE for multiple licensed and pending vaccines. The results of this project will inform best practices for diagnosis and treatment, guide vaccine recommendations, and determine public health interventions to prevent viral illness-related medical visits among children.