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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 144-147 |
| Number of pages | 4 |
| Journal | Journal of the Pediatric Infectious Diseases Society |
| Volume | 13 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 1 2024 |
Funding
Potential conflicts of interest: R.D. has received grants or contracts from AstraZeneca, Merck, and Pfizer; consulting fees from Merck and Pfizer; and honoraria from GSK, Merck, Pfizer, and Sanofi Pasteur. L.L.H has received grants to her institution from AstraZeneca, Merck, and Pfizer. M.B.C. and M.B. report no conflicts of interest. S.A.M. has received grants or contracts from the Bill and Melinda Gates Foundation, GSK, MinervaX, Pfizer, and the South African Medical Research Council; has received payments or honoraria from the Bill and Melinda Gates Foundation; and has participated in data safety monitoring boards or advisory boards for PATH and CAPRISA. W.J.M. has received grants or contracts from Ansun, Astellas, AstraZeneca, Eli Lilly, Enanta Pharmaceuticals, Genentech, Gilead, Janssen, Karius, Melinta, Merck, Moderna, Nabriva, Paratek, Pfizer, and Tetraphase; consulting fees from Finley Law Firm and Seqirus; has received payment or honoraria from Contemporary Pediatrics; and has participated in data safety monitoring boards or advisory boards for Adagio Therapeutics, AstraZeneca, ProventionBio, and Sanofi Pasteur. H.J.Z. has received grants or contracts from AstraZeneca, MSD, and Pfizer; and has received payment or honoraria from Merck. B.S.N., Y.C., A.C, A.G., M.S., T.T., V.S.M., and T.V. are employees of AstraZeneca and may hold stock or stock options. A.L. is a former employee of AstraZeneca and may hold stock or stock options. Financial support: This study was supported by AstraZeneca and Sanofi. AstraZeneca was involved in the trial design; the collection, analysis, and interpretation of the data; and the writing of the manuscript. Nirsevimab is being developed and commercialized in partnership between AstraZeneca and Sanofi. We thank the trial participants and their families; the team at IQVIA; the members of the independent data and safety monitoring committee (Larry Givner, MD [chair], William Blackwelder, PhD [biostatistician], and John Modlin, PhD); the members of the investigator teams; the full clinical team at AstraZeneca; and Rebecca A. Bachmann, PhD, for assistance with manuscript preparation. Medical writing support, under the direction of the authors, was provided by Richard Knight, PhD, CMC Connect, a division of IPG Health Medical Communications, in accordance with Good Publication Practice (GPP) 2022 guidelines (https://www.ismpp.org/ gpp-2022; Ann Intern Med. 2022 doi:10.7326/M22-1460) and was funded by AstraZeneca. Nirsevimab is being developed in partnership between AstraZeneca and Sanofi.
Keywords
- immunization
- monoclonal antibody
- nirsevimab
- respiratory syncytial virus
ASJC Scopus subject areas
- General Medicine
