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: 10472389
• 负责人: JANET A ENGLUND
• 金额: $ 193.33万
• 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/10472389
• 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、预期的住院患者、急诊科(ED)和无症状的 西雅图SCH及其附属诊所儿童健康对照(HC)监测 都会区。我们将招收描述以人口为基础的年龄负担和 华盛顿州金县和斯诺霍米什县的ARI和评估许可证的有效性 流感疫苗(流感)和轮状病毒疫苗(VX)。我们将评估 儿童呼吸道和肠道病毒病的流行病学和自然病史及评估 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。在获得后 知情同意和同意，如适用，我们将以英语或西班牙语与家属面谈 收集流行病学和临床信息、疫苗历史，并获取研究样本 包括呼吸道和/或粪便样本，视临床症状而定。疫苗接种数据 记录在我们的州疫苗数据库中，这是非常可靠和完整的。在……期间 新冠肺炎，可以根据IRB使用新的注册和捕获数据的方法- 批准的协议包括口头或在线同意、电话采访以完成数据 捕获，并收集回家的标本。呼吸道样本和粪便样本将进行测试 使用敏感和特异的分子聚合酶链式反应检测多种呼吸道和肠道病原体 在实验室中使用已通过能力测试验证的经批准的测试策略。 有了这些信息，除了可以公开获得的全州范围内描述住院患者和 在西澳的急诊，我们将获得急症和住院就诊的发病率和 多种病毒病原体的疾病特征，包括那些导致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、 腺病毒和人类偏肺病毒。此外，我们将继续进行监视 用于整个佤邦的急性弛缓性脊髓炎(AFM)。与全州AFM合作 专家兼SCH神经学家凯瑟琳·奥滕博士和使用西澳卫生局监测数据，我们将 进行主动监测，建立发病率，并将AFM的发病率与当前的 呼吸道和胃肠道感染的循环。我们将描述临床的特点 通过评估临床和实验室数据、MRI表现、治疗情况来评估AFM的频谱 干预措施和结果，为早期诊断、预后、预防和治疗提供信息。