Infants Receiving a Single Dose of Nirsevimab to Prevent RSV Do Not Have Evidence of Enhanced Disease in Their Second RSV Season

Ron Dagan¹, Laura L Hammitt², Beatriz Seoane Nuñez³, Manuel Baca Cots⁴, Miroslava Bosheva⁵, Shabir A Madhi⁶, William J Muller^{7

8}, Heather J Zar⁹, Yue Chang¹⁰, Alexander Currie¹¹, Amy Grenham¹⁰, Manish Shroff¹², Therese Takas¹⁰, Vaishali S Mankad¹³, Amanda Leach¹⁰, Tonya Villafana¹⁰

Affiliations

¹ The Shraga Segal Department of Microbiology, Immunology and Genetics, Faculty of Health Sciences at the Ben-Gurion University of the Negev, Beer-Sheva, Israel.
² Department of International Health, Johns Hopkins University, Baltimore, Maryland, USA.
³ Biometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Madrid, Spain.
⁴ Paediatric Service, Quirónsalud Málaga Hospital, Málaga, Spain.
⁵ Paediatrics, University Multiprofile, Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria.
⁶ South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
⁷ Infectious Diseases, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.
⁸ Stanley Manne Children's Research Institute, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
⁹ Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town, South Africa.
¹⁰ Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
¹¹ Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
¹² Patient Safety, Chief Medical Office, R&D, AstraZeneca, Waltham, Massachusetts, USA.
¹³ Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Durham, North Carolina, USA.

PMID: 38219024
PMCID: PMC10896255
DOI: 10.1093/jpids/piad113

Clinical Trial

Infants Receiving a Single Dose of Nirsevimab to Prevent RSV Do Not Have Evidence of Enhanced Disease in Their Second RSV Season

Ron Dagan et al. J Pediatric Infect Dis Soc. 2024.

. 2024 Feb 26;13(2):144-147.

doi: 10.1093/jpids/piad113.

Authors

Affiliations

¹ The Shraga Segal Department of Microbiology, Immunology and Genetics, Faculty of Health Sciences at the Ben-Gurion University of the Negev, Beer-Sheva, Israel.
² Department of International Health, Johns Hopkins University, Baltimore, Maryland, USA.
³ Biometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Madrid, Spain.
⁴ Paediatric Service, Quirónsalud Málaga Hospital, Málaga, Spain.
⁵ Paediatrics, University Multiprofile, Hospital for Active Treatment, St. George Medical University, Plovdiv, Bulgaria.
⁶ South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit and African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
⁷ Infectious Diseases, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.
⁸ Stanley Manne Children's Research Institute, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
⁹ Department of Paediatrics and Child Health, Red Cross Children's Hospital, and the Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, Cape Town, South Africa.
¹⁰ Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
¹¹ Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
¹² Patient Safety, Chief Medical Office, R&D, AstraZeneca, Waltham, Massachusetts, USA.
¹³ Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Durham, North Carolina, USA.

PMID: 38219024
PMCID: PMC10896255
DOI: 10.1093/jpids/piad113

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.

Keywords: immunization; monoclonal antibody; nirsevimab; respiratory syncytial virus.

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References

1. Li Y, Wang X, Blau DM, et al. ; Respiratory Virus Global Epidemiology Network. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet 2022; 399:2047–64. - PMC - PubMed
1. Rha B, Curns AT, Lively JY, et al. . Respiratory syncytial virus-associated hospitalizations among young children: 2015-2016. Pediatrics 2020; 146:e20193611. - PubMed
1. PATH. RSV Vaccine and mAb Snapshot. https://www.path.org/resources/rsv-vaccine-and-mab-snapshot/Accessed November 17, 2023.
1. van Erp EA, Luytjes W, Ferwerda G, van Kasteren PB.. Fc-mediated antibody effector functions during respiratory syncytial virus infection and disease. Front Immunol 2019; 10:548. - PMC - PubMed
1. Lee WS, Wheatley AK, Kent SJ, DeKosky BJ.. Antibody-dependent enhancement and SARS-CoV-2 vaccines and therapies. Nat Microbiol 2020; 5:1185–91. - PubMed

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Infants Receiving a Single Dose of Nirsevimab to Prevent RSV Do Not Have Evidence of Enhanced Disease in Their Second RSV Season

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Infants Receiving a Single Dose of Nirsevimab to Prevent RSV Do Not Have Evidence of Enhanced Disease in Their Second RSV Season

Authors

Affiliations

Abstract

References

Publication types

MeSH terms

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Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical