IP21-002, New Vaccine Surveillance Network

SUMMARY (For Components A, B, and C). Acute gastroenteritis (AGE) and acute respiratory illness (ARI) are leading causes of childhood disease, accounting for a large proportion of hospitalizations, Emergency Department (ED) visits, and outpatient visits annually in the US. These illnesses are caused by diverse pathogens, including influenza, respiratory syncytial virus, human metapneumovirus, parainfluenza viruses, rhinovirus, enterovirus (EV), coronavirus including SARS-CoV-2, adenovirus, rotavirus, norovirus, astrovirus, and sapovirus. Moreover, some of these viruses are associated with other emerging childhood syndromes, including acute flaccid myelitis (AFM) associated with EV, and multisystem inflammatory syndrome in children (MIS-C) associated with SARS-CoV-2. Thus, viral AGE and ARI are of major public health importance, and result in serious long-term consequences for some children. There are few or no effective antivirals for these viruses and vaccination is the most promising intervention. Our goals are to conduct active, prospective population-based surveillance for AGE and ARI; to define the burden of vaccine-preventable diseases; describe the clinical features, natural history, and population dynamics; and establish vaccine effectiveness (VE) of licensed and impending vaccines and monitor VE over time. The New Vaccine Surveillance Network (NVSN) will facilitate these goals. We propose four Specific Aims: Aim 1: to conduct prospective active surveillance for AGE due to norovirus, rotavirus, and other enteric viruses among children seeking healthcare in ED, inpatient, and outpatient settings. (Component A, Mandatory Component 1; Optional Component B) Aim 2: to conduct prospective active surveillance for ARI due to respiratory viruses in these settings. (Component A, Mandatory Component 1; Optional Component B) Aim 3: to conduct prospective active surveillance for AFM syndrome in these settings. (Component A, Mandatory Component 2) Aim 4: to conduct prospective active surveillance for MIS-C. (Optional Component C) The Pittsburgh site has extensive experience with pediatric clinical research, including as a top enrolling NVSN site in the current NVSN cycle. UPMC Children’s Hospital of Pittsburgh (CHP) has a catchment area of >5.5 million people and admits >95% of hospitalized children in the surrounding county of >1.2 million. Thus, the environment is excellent for population-based research. The experienced investigative team includes experts from pediatric infectious diseases, critical care, rheumatology, and cardiology. The data and samples collected in this project will facilitate the capacity to calculate VE for multiple licensed and pending vaccines. The results of this project will inform best practices for diagnosis and treatment, guide vaccine recommendations, and determine public health interventions to prevent viral illness-related medical visits among children.