2. Academic Validation
  3. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants

Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants

  • N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556.
M Pamela Griffin 1,  Yuan Yuan 1,  Therese Takas 1,  Joseph B Domachowske 1,  Shabir A Madhi 1,  Paolo Manzoni 1,  Eric A F Simões 1,  Mark T Esser 1,  Anis A Khan 1,  Filip Dubovsky 1,  Tonya Villafana 1,  John P DeVincenzo 1,  Nirsevimab Study Group
Affiliations

Affiliation

  • 1 From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).
PMID: 32726528 DOI: 10.1056/NEJMoa1913556
Abstract

Background: Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract Infection in infants, and a need exists for prevention of RSV in healthy infants. Nirsevimab is a monoclonal antibody with an extended half-life that is being developed to protect infants for an entire RSV season with a single intramuscular dose.

Methods: In this trial conducted in both northern and southern hemispheres, we evaluated nirsevimab for the prevention of RSV-associated lower respiratory tract Infection in healthy infants who had been born preterm (29 weeks 0 days to 34 weeks 6 days of gestation). We randomly assigned the infants in a 2:1 ratio to receive nirsevimab, at a dose of 50 mg in a single intramuscular injection, or placebo at the start of an RSV season. The primary end point was medically attended RSV-associated lower respiratory tract Infection through 150 days after administration of the dose. The secondary efficacy end point was hospitalization for RSV-associated lower respiratory tract Infection through 150 days after administration of the dose.

Results: From November 2016 through November 2017, a total of 1453 infants were randomly assigned to receive nirsevimab (969 infants) or placebo (484 infants) at the start of the RSV season. The incidence of medically attended RSV-associated lower respiratory tract Infection was 70.1% lower (95% confidence interval [CI], 52.3 to 81.2) with nirsevimab prophylaxis than with placebo (2.6% [25 infants] vs. 9.5% [46 infants]; P<0.001) and the incidence of hospitalization for RSV-associated lower respiratory tract Infection was 78.4% lower (95% CI, 51.9 to 90.3) with nirsevimab than with placebo (0.8% [8 infants] vs. 4.1% [20 infants]; P<0.001). These differences were consistent throughout the 150-day period after the dose was administered and across geographic locations and RSV subtypes. Adverse events were similar in the two trial groups, with no notable hypersensitivity reactions.

Conclusions: A single injection of nirsevimab resulted in fewer medically attended RSV-associated lower respiratory tract infections and hospitalizations than placebo throughout the RSV season in healthy preterm infants. (Funded by AstraZeneca and Sanofi Pasteur; ClinicalTrials.gov number, NCT02878330.).

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