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<p>As part of the NIRSEGAL study (<a href="https://www.nirsegal.es/en">https://www.nirsegal.es/en</a>), we present the clinical characteristics and course of respiratory syncytial virus (RSV)-related low respiratory tract infection (LRTI) hospitalizations in infants eligible for nirsevimab administration during the 2023–2024 season. Infants eligible for nirsevimab immunization (born between 1 April, 2023, and 30 March, 2024) who were hospitalized due to RSV-related LRTI between September 25, 2023, and April 15, 2024, in a hospital from the Galician Public Health system were included. Clinical and demographic characteristics of RSV-related LRTI hospitalizations were analyzed, with comparisons made between breakthrough cases (those immunized with nirsevimab) and non-breakthrough cases. During the study period, 69 RSV-related LRTI hospitalizations were recorded, with a median hospital stay of 4 (interquartile range (IQR) 3–6) days; 65.2% (<i>N</i> = 45) were breakthrough cases. The median age was 2.7 (IQR 1.5–5.2) months, and more than half of them (<i>N</i> = 39, 56.5%) were male. The incidence of cases was parallel to the RSV epidemic curve, suggesting no waning of nirsevimab efficacy. Of the total hospitalizations, 16 infants (23.2%) had a high-risk condition, 44 (63.8%) needed oxygen support, 15 (21.7%) were admitted to the intensive care unit (ICU), and 11 (15.9%) received non-invasive mechanical ventilation (NIMV). No statistically significant differences were observed in these characteristics when comparing breakthrough and non-breakthrough cases. <i>Conclusion</i>: In the nirsevimab era, a substantial proportion of children who were hospitalized for RSV-related LRTI needed oxygen support, NIMV, and ICU admission. Clinical characteristics, timing, and outcomes were comparable between breakthrough and non-breakthrough cases.</p><p><i>Trial registration</i>: The NIRSE-GAL study protocol was registered on ClinicalTrials.gov (NCT06180993).<Table Float="No" ID="Taba"> <tgroup cols="2"> <colspec align="left" colname="c1" colnum="1" /> <colspec align="left" colname="c2" colnum="2" /> <tbody> <row> <entry nameend="c2" namest="c1"> <p><b>What is Known</b>:</p> <p>• <i>Nirsevimab, a long-acting monoclonal antibody, has shown high effectiveness in preventing RSV-related hospitalizations and has been included in some European countries’ immunization programs</i>.</p> </entry> </row> <row> <entry nameend="c2" namest="c1"> <p><b>What is New:</b></p> <p>• <i>During the first RSV season after the universal implementation of nirsevimab in Galicia (Spain), a large proportion of hospitalized infants had high-risk conditions, yet disease severity markers (oxygen need, ICU admission, NIVM) were comparable between breakthrough and non-breakthrough cases</i>.</p> <p>• <i>No signal of waning protection over time was observed among breakthrough cases, reinforcing the potential value of early, season-wide immunization</i>.</p> </entry> </row> </tbody> </tgroup> </Table></p>

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Respiratory syncytial virus–related lower respiratory tract infection hospitalizations in infants receiving nirsevimab in Galicia (Spain): the NIRSE-GAL study

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  • 发表日期：

    2025年5月2日

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  • Angela Manzanares,
  • Jacobo Pardo-Seco,
  • Irene Rivero-Calle,
  • Ana Dacosta-Urbieta,
  • Narmeen Mallah,
  • María-Isolina Santiago-Pérez,
  • Olaia Pérez-Martínez,
  • María-Teresa Otero-Barrós,
  • Nuria Suárez-Gaiche,
  • Rolf Kramer,
  • Jing Jin,
  • Leticia Platero-Alonso,
  • Rosa-María Alvárez-Gil,
  • Olga-María Ces-Ozores,
  • Victoria Nartallo-Penas,
  • Susana Mirás-Carballal,
  • Marta Piñeiro-Sotelo,
  • Juan-Manuel González-Pérez,
  • Carmen Rodríguez-Tenreiro-Sánchez,
  • Antonio Salas,
  • Carmen Durán-Parrondo,
  • Federico Martinón-Torres

摘要

As part of the NIRSEGAL study (https://www.nirsegal.es/en), we present the clinical characteristics and course of respiratory syncytial virus (RSV)-related low respiratory tract infection (LRTI) hospitalizations in infants eligible for nirsevimab administration during the 2023–2024 season. Infants eligible for nirsevimab immunization (born between 1 April, 2023, and 30 March, 2024) who were hospitalized due to RSV-related LRTI between September 25, 2023, and April 15, 2024, in a hospital from the Galician Public Health system were included. Clinical and demographic characteristics of RSV-related LRTI hospitalizations were analyzed, with comparisons made between breakthrough cases (those immunized with nirsevimab) and non-breakthrough cases. During the study period, 69 RSV-related LRTI hospitalizations were recorded, with a median hospital stay of 4 (interquartile range (IQR) 3–6) days; 65.2% (N = 45) were breakthrough cases. The median age was 2.7 (IQR 1.5–5.2) months, and more than half of them (N = 39, 56.5%) were male. The incidence of cases was parallel to the RSV epidemic curve, suggesting no waning of nirsevimab efficacy. Of the total hospitalizations, 16 infants (23.2%) had a high-risk condition, 44 (63.8%) needed oxygen support, 15 (21.7%) were admitted to the intensive care unit (ICU), and 11 (15.9%) received non-invasive mechanical ventilation (NIMV). No statistically significant differences were observed in these characteristics when comparing breakthrough and non-breakthrough cases. Conclusion: In the nirsevimab era, a substantial proportion of children who were hospitalized for RSV-related LRTI needed oxygen support, NIMV, and ICU admission. Clinical characteristics, timing, and outcomes were comparable between breakthrough and non-breakthrough cases.

Trial registration: The NIRSE-GAL study protocol was registered on ClinicalTrials.gov (NCT06180993).

What is Known:

• Nirsevimab, a long-acting monoclonal antibody, has shown high effectiveness in preventing RSV-related hospitalizations and has been included in some European countries’ immunization programs.

What is New:

• During the first RSV season after the universal implementation of nirsevimab in Galicia (Spain), a large proportion of hospitalized infants had high-risk conditions, yet disease severity markers (oxygen need, ICU admission, NIVM) were comparable between breakthrough and non-breakthrough cases.

• No signal of waning protection over time was observed among breakthrough cases, reinforcing the potential value of early, season-wide immunization.