IP21-002, Enhanced Surveillance to Assess Vaccine Preventable Enteric and Respiratory Virus Illnesses

IP21-002，加强监测以评估疫苗可预防的肠道和呼吸道病毒疾病

• 批准号: 10343251
• 负责人: JANET A ENGLUND
• 金额: $ 144.16万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 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/10343251
• 关键词: IP21; 002; Enhanced; Surveillance; Assess

We will conduct active, prospective inpatient, emergency department (ED) and asymptomatic healthy control (HC) surveillance in children at SCH and affiliated clinics in the Seattle metropolitan area. We will enroll subjects to describe the population-based burden of AGE and ARI in King County and Snohomish County, WA and evaluate effectiveness of licensed vaccines, such as influenza (Flu) and rotavirus (RV) vaccine (vx). We will assess the epidemiology and natural history of pediatric respiratory and enteric viral diseases and assess transmission dynamics for vx-preventable (RV, Flu) and potentially vx-preventable pathogens, such as norovirus (NV), respiratory syncytial virus (RSV), and SARS-CoV-2. After obtaining informed consent and assent, if applicable, in English or Spanish, we will interview families to collect epidemiological and clinical information, vaccine history, and obtain study specimens including respiratory and/or stool specimens, depending on clinical symptoms. Vaccination data are recorded in our state vaccine database, which is very reliable and complete. During times of COVID-19, novel methods of enrollment and capturing data may be utilized as per IRB- approved protocols including verbal or online consent, telephone interviews to complete data capture, and home specimen collection. Respiratory specimens and stool samples will be tested for multiple respiratory and enteric pathogens using sensitive and specific molecular PCR tests in laboratories using approved testing strategies that have been validated by proficiency testing. With this information, in addition to publicly available state-wide data describing inpatient and acute care visits in WA, we will obtain incidence rates of ED and inpatient visits and characterization of illness for multiple viral pathogens, including those responsible for vx- preventable disease and potentially vx-preventable disease, and others related to acute respiratory and enteric diseases, such as rhinovirus, EVD-68, parainfluenza viruses, adenoviruses, and human metapneumovirus. Additionally, we will continue ongoing surveillance for Acute Flaccid Myelitis (AFM) throughout WA state. In collaboration with statewide AFM expert and SCH neurologist, Dr. Catherine Otten and using WA DOH surveillance data we will conduct active surveillance, establish incidence rates, and compare rates of AFM to current circulation of respiratory and gastrointestinal infections. We will characterize the clinical spectrum of AFM by evaluating clinical and laboratory data, MRI findings, therapeutic interventions, and outcomes to inform early diagnosis, prognosis, prevention, and treatment.

我们将进行积极的，前瞻性的住院，急诊科（艾德）和无症状 在西雅图的SCH和附属诊所对儿童进行健康控制（HC）监测 大都会区。我们将招募受试者，以描述基于人群的AGE负担， ARI在华盛顿州国王县和斯诺霍米什县，并评估许可的有效性 疫苗，如流感（Flu）和轮状病毒（RV）疫苗（vx）。我们将评估 儿科呼吸道和肠道病毒性疾病的流行病学和自然史，并评估 VX可预防（RV、流感）和潜在VX可预防病原体的传播动力学， 如诺如病毒（NV）、呼吸道合胞病毒（RSV）和SARS-CoV-2。在得到 知情同意书和同意书，如果适用，用英语或西班牙语，我们将采访家庭， 收集流行病学和临床信息、疫苗接种史，并获得研究样本 包括呼吸道和/或粪便样本，取决于临床症状。接种数据 都记录在我们国家的疫苗数据库里，这个数据库是非常可靠和完整的。During times of COVID-19，可根据IRB使用新的入组和采集数据的方法- 批准的方案，包括口头或在线同意，电话访谈以完成数据 捕获和家庭标本采集。将检测呼吸道标本和粪便样本 使用敏感和特异的分子PCR检测多种呼吸道和肠道病原体 在实验室使用已通过能力验证的批准的测试策略。 有了这些信息，除了公开的全州范围内的数据描述住院病人和 在西澳的急诊就诊中，我们将获得艾德和住院就诊的发病率， 多种病毒病原体的疾病特征，包括导致vx的病原体， 可预防的疾病和潜在的VX可预防的疾病，以及其他与急性 呼吸道和肠道疾病，如鼻病毒，EVD-68，副流感病毒， 腺病毒和人偏肺病毒。另外，我们会继续监视 急性弛缓性肌无力症（AFM）在整个西澳州。与全州AFM合作 专家和SCH神经学家，凯瑟琳Otten博士和使用WA DOH监测数据，我们将 进行积极的监测，确定发病率，并将AFM的发病率与目前的发病率进行比较。 呼吸道和胃肠道感染的循环。我们将描述临床 通过评估临床和实验室数据，MRI结果，治疗 干预措施和结果，为早期诊断、预后、预防和治疗提供信息。