IP21-002, New Vaccine Surveillance Network

总结（对于组分A、B和C）。急性肠胃炎（AGE）和急性呼吸道疾病（ARI） 是儿童疾病的主要原因，占住院治疗的很大比例， 美国每年的科室（艾德）访视和门诊访视。这些疾病是由多种 病原体，包括流感、呼吸道合胞病毒、人偏肺病毒、副流感病毒， 鼻病毒、肠道病毒（EV）、冠状病毒（包括SARS-CoV-2）、腺病毒、轮状病毒、诺如病毒、星状病毒， 和沙波病毒。此外，其中一些病毒与其他新出现的儿童综合征有关， 包括与EV相关的急性弛缓性肌病（AFM）和儿童多系统炎症综合征 （MIS-C）与SARS-CoV-2相关。因此，病毒性AGE和ARI具有重大的公共卫生重要性， 对一些儿童造成严重的长期后果。很少或没有有效的抗病毒药物， 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 以人口为基础的老龄化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、自然史和种群动态;并确定疫苗有效性 (VE)获得许可的和即将到来的疫苗，并随着时间的推移监测VE。新的疫苗监测网络 （NVSN）将促进这些目标。我们提出四个具体目标： 目的1：对由诺如病毒、轮状病毒和其他病毒引起的AGE进行前瞻性主动监测， 在艾德、住院和门诊就诊的儿童中的肠道病毒。 （组分A、必备组分1;可选组分B） 目的2：在这些环境中对呼吸道病毒引起的ARI进行前瞻性主动监测。 （组分A、必备组分1;可选组分B） 目的3：在这些环境中对AFM综合征进行前瞻性主动监测。（组分A， 强制性组件2） 目标4：对MIS-C进行前瞻性主动监测。（任选组分C） 匹兹堡临床试验机构在儿科临床研究方面拥有丰富的经验，包括作为最佳招募NVSN 在当前的NVSN周期中。匹兹堡UPMC儿童医院（CHP）的集水区面积>5.5 该医院的住院儿童超过120万人，占周边县住院儿童的95%以上。因此 环境对于以人口为基础的研究来说是极好的。经验丰富的调查小组包括专家 儿科传染病、重症监护、风湿病学和心脏病学。收集的数据和样本 本项目中的信息将促进计算多种许可和待批准疫苗的VE的能力。结果 该项目的成果将为诊断和治疗提供最佳实践，指导疫苗推荐， 确定公共卫生干预措施，以防止儿童因病毒性疾病就医。

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.