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: 10674580
• 负责人: JANET A ENGLUND
• 金额: $ 275万
• 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/10674580
• 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.

我们将积极、前瞻性地对住院患者、急诊科 (ED) 和无症状患者进行筛查 对西雅图 SCH 及其附属诊所的儿童进行健康控制 (HC) 监测 大都市区。我们将招募受试者来描述基于人群的 AGE 负担， 华盛顿州金县和斯诺霍米什县的 ARI 并评估许可的有效性 疫苗，例如流感 (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态， 例如诺如病毒 (NV)、呼吸道合胞病毒 (RSV) 和 SARS-CoV-2。获得后 以英语或西班牙语提供知情同意书和同意书（如果适用），我们将与家人面谈 收集流行病学和临床信息、疫苗史并获取研究标本 包括呼吸道和/或粪便标本，具体取决于临床症状。疫苗接种数据 记录在我们的国家疫苗数据库中，该数据库非常可靠和完整。期间 COVID-19，可以根据IRB-使用新的登记和捕获数据方法 批准的协议，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。将检测呼吸道样本和粪便样本 使用敏感且特异的分子 PCR 测试检测多种呼吸道和肠道病原体 在实验室中使用经能力验证验证的批准测试策略。 有了这些信息，除了描述住院患者和患者的公开可用的全州范围数据外， 在西澳的急症护理就诊，我们将获得急诊科和住院患者就诊的发生率，以及 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，以及与急性相关的其他疾病 呼吸道和肠道疾病，如鼻病毒、EVD-68、副流感病毒、 腺病毒和人类偏肺病毒。此外，我们将继续持续监控 整个西澳州的急性弛缓性脊髓炎 (AFM)。与全州 AFM 合作 专家兼 SCH 神经学家 Catherine Otten 博士并使用 WA DOH 监测数据，我们将 进行主动监测，确定发病率，并将 AFM 发生率与当前发生率进行比较 呼吸道和胃肠道感染的循环。我们将描述临床特征 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。