Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants
- PMID: 32726528
- DOI: 10.1056/NEJMoa1913556
Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants
Erratum in
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Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants.N Engl J Med. 2020 Aug 13;383(7):698. doi: 10.1056/NEJMx200019. Epub 2020 Jul 29. N Engl J Med. 2020. PMID: 32730699 No abstract available.
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.).
Copyright © 2020 Massachusetts Medical Society.
Comment in
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Single-dose nirsevimab prevents RSV infection.J Pediatr. 2021 Jan;228:310-313. doi: 10.1016/j.jpeds.2020.10.066. J Pediatr. 2021. PMID: 33342497 No abstract available.
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Nirsevimab reduces medically attended RSV-associated lower respiratory tract infection and hospitalisations in healthy pre-term infants.Arch Dis Child Educ Pract Ed. 2022 Aug;107(4):310-311. doi: 10.1136/archdischild-2020-321141. Epub 2021 Feb 17. Arch Dis Child Educ Pract Ed. 2022. PMID: 33597216 No abstract available.
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