Infants Receiving a Single Dose of Nirsevimab to Prevent RSV Do Not Have Evidence of Enhanced Disease in Their Second RSV Season
Ron Dagan, Laura L. Hammitt, Beatriz Seoane Núñez, Manuel Baca Cots, Miroslava Bosheva, Shabir A. Madhi, William J. Muller, Heather J. Zar, Yue Chang, Alexander Currie, Amy Grenham, Manish Shroff, Therese Takas, Vaishali S. Mankad, Amanda Leach, Tonya Villafana
Abstract
To characterize nirsevimab in the prevention of RSV, children from the Phase 3 MELODY trial were followed through their second RSV season. No increase in medically attended RSV lower respiratory tract infections or evidence of antibody-dependent enhancement of infection or disease severity was found for nirsevimab vs placebo recipients. Clinical Trial Registration: Clinicaltrials.gov, NCT03979313, https://clinicaltrials.gov/ct2/show/NCT03979313.
Topics & Concepts
MedicinePlaceboRespiratory tract infectionsClinical trialDiseaseAntibodyInternal medicineUpper respiratory tract infectionPediatricsImmunologyRespiratory systemAlternative medicinePathologyRespiratory viral infections researchPneumonia and Respiratory InfectionsViral gastroenteritis research and epidemiology