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

  • Funded by National Institutes of Health (NIH)
  • Total publications:0 publications

Grant number: 6U01IP001157-03M002

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Key facts

  • Disease

    COVID-19, Middle East respiratory syndrome coronavirus (MERS)
  • Start & end year

    2021
    2026
  • Known Financial Commitments (USD)

    $2,300,000
  • Funder

    National Institutes of Health (NIH)
  • Principal Investigator

    PROFESSOR JANET ENGLUND
  • Research Location

    United States of America
  • Lead Research Institution

    SEATTLE CHILDREN'S HOSPITAL
  • Research Priority Alignment

    N/A
  • Research Category

    Epidemiological studies

  • Research Subcategory

    Disease transmission dynamics

  • Special Interest Tags

    Data Management and Data Sharing

  • Study Type

    Clinical

  • Clinical Trial Details

    Not applicable

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

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.