IP21-002, US Enhanced Surveillance Network to Assess Burden, Natural History, and Effectiveness of Vaccines to Prevent Enteric and Respiratory Viruses in Children

Component A: Project Summary The Kansas City-New Vaccine Surveillance Network (KC-NVSN) program has been performing population-based, laboratory-confirmed, active surveillance of acute gastroenteritis (AGE) illness and acute respiratory illness (ARI) in children seeking care at Children's Mercy (CM), in Kansas City (KC), MO since 2009 and 2015, respectively. In the current proposal, the KC-NVSN program seeks to continue the existing pediatric AGE and expand the pediatric ARI surveillance to the six county KC metropolitan area for children seen in CM's inpatient and emergency department (ED) settings. Age- and time-matched healthy control children seeking well-child care in the outpatient setting will also be enrolled. We will enroll eligible children (as defined in the proposal) visiting or admitted to our hospital system using permission and assent forms approved by CM's institutional review board (IRB). After enrollment, we will interview parents, collect EMR chart data, and retrieve hard copies of receipt of influenza and rotavirus (RV) vaccine, and any future vaccines (SARS-CoV-2, RSV, NoV). Stool specimens will be tested for RV, norovirus (NoV), and other GI pathogens, and respiratory specimens for 23 respiratory pathogens, e.g., influenza (types and specific subtypes) and other non-influenza viruses (RSV, EV-D68, and SARS-CoV-2, etc). We will use prospective surveillance for acute flaccid myelitis (AFM) characterizing the clinical disease spectrum and burden rates. KC-NVSN data will provide population-based estimates to address the following specific aims: 1. To assess the burden of AGE and ARI pathogens among enrolled children. 2. To assess vaccine effectiveness (VE) against medically attended illness due to RV, influenza, and upcoming vaccines via laboratory-confirmed testing among enrolled children. 3. To assess AFM clinical spectra and burden and associations with ARI and AGE illnesses. The KC-NVSN program data will be combined with other geographically diverse sites' data to estimate the national incidence, burden, and etiology of community-acquired AGE and ARI and VE for rotavirus and seasonal influenza vaccinations. This network will also address several important scientific questions related to the natural history of pediatric infectious diseases, transmission dynamics, impact of vaccine on targeted and vulnerable populations, and factors influencing VE. The surveillance data generated from this network will provide timely and highly useful data to inform public health measures and pediatric vaccine-related policies aimed at controlling AGE and ARI in US children.