Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants

Drysdale, Simon B., Cathie, Katrina, Flamein, Florence, Knuf, Markus, Collins, Andrea M., Hill, Helen C., Kaiser, Friedrich, Cohen, Robert, Pinquier, Didier, Felter, Christian T., Vassilouthis, Natalya C., Jin, Jing, Bangert, Mathieu, Mari, Karine, Nteene, Rapi, Wague, Sophie, Roberts, Michelle, Tissières, Pierre, Royal, Simon and Faust, Saul N. and HARMONIE Study Group (2023) Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants. New England Journal of Medicine, 389 (26). pp. 2425-2435. ISSN 0028-4793

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Abstract

Background The safety of the monoclonal antibody nirsevimab and the effect of nirsevimab on hospitalizations for respiratory syncytial virus (RSV)-associated lower respiratory tract infection when administered in healthy infants are unclear.  Methods In a pragmatic trial, we randomly assigned, in a 1:1 ratio, infants who were 12 months of age or younger, had been born at a gestational age of at least 29 weeks, and were entering their first RSV season in France, Germany, or the United Kingdom to receive either a single intramuscular injection of nirsevimab or standard care (no intervention) before or during the RSV season. The primary end point was hospitalization for RSV-associated lower respiratory tract infection, defined as hospital admission and an RSV-positive test result. A key secondary end point was very severe RSV-associated lower respiratory tract infection, defined as hospitalization for RSV-associated lower respiratory tract infection with an oxygen saturation of less than 90% and the need for supplemental oxygen.  Results A total of 8058 infants were randomly assigned to receive nirsevimab (4037 infants) or standard care (4021 infants). Eleven infants (0.3%) in the nirsevimab group and 60 (1.5%) in the standard-care group were hospitalized for RSV-associated lower respiratory tract infection, which corresponded to a nirsevimab efficacy of 83.2% (95% confidence interval [CI], 67.8 to 92.0; P<0.001). Very severe RSV-associated lower respiratory tract infection occurred in 5 infants (0.1%) in the nirsevimab group and in 19 (0.5%) in the standard-care group, which represented a nirsevimab efficacy of 75.7% (95% CI, 32.8 to 92.9; P=0.004). The efficacy of nirsevimab against hospitalization for RSV-associated lower respiratory tract infection was 89.6% (adjusted 95% CI, 58.8 to 98.7; multiplicity-adjusted P<0.001) in France, 74.2% (adjusted 95% CI, 27.9 to 92.5; multiplicity-adjusted P=0.006) in Germany, and 83.4% (adjusted 95% CI, 34.3 to 97.6; multiplicity-adjusted P=0.003) in the United Kingdom. Treatment-related adverse events occurred in 86 infants (2.1%) in the nirsevimab group.  Conclusions Nirsevimab protected infants against hospitalization for RSV-associated lower respiratory tract infection and against very severe RSV-associated lower respiratory tract infection in conditions that approximated real-world settings. (Funded by Sanofi and AstraZeneca; HARMONIE ClinicalTrials.gov number, NCT05437510).

Item Type:	Article
Additional Information:	Funding Information: Supported by Sanofi and AstraZeneca . Publisher Copyright: © 2023 Massachusetts Medical Society.
Uncontrolled Keywords:	childhood diseases,global health,immunization,infectious disease,infectious disease general,pediatrics,vaccines,viral infections,medicine(all),sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700
Faculty \ School:	Faculty of Medicine and Health Sciences > Norwich Medical School
Related URLs:	http://www.scopus.com/inward/record.url?...
Depositing User:	LivePure Connector
Date Deposited:	10 Dec 2024 01:45
Last Modified:	16 Dec 2024 01:43
URI:	https://ueaeprints.uea.ac.uk/id/eprint/97956
DOI:	10.1056/NEJMoa2309189

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