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Journal Article Epublish 17 citations

PubMed: 40006722 DOI: 10.3390/vaccines13020175

Nirsevimab Prophylaxis for Reduction of Respiratory Syncytial Virus Complications in Hospitalised Infants: The Multi-Centre Study During the 2023-2024 Season in Andalusia, Spain (NIRSEGRAND).

Vaccines (Basel) 13(2)

Authors: David Moreno-Pérez, Aleksandra Korobova, Francisco de Borja Croche-Santander, Ana Cordón-Martínez, Olga Díaz-Morales, Leticia Martínez-Campos, Elena Pérez-González, María Del Carmen Martínez-Padilla, Juan Luis Santos-Pérez, Jaime Brioso-Galiana, María Isabel Sánchez-Códez, Jorge Del Diego-Salas, Mario Rivera-Izquierdo, Nicola Lorusso

Affiliations

  • Health and Consumption Department, General Directorate of Public Health and Pharmaceutical Management of Andalusia, 41020 Seville, Spain.
  • Department of Paediatrics at the Malaga Mother-and-Child Hospital, Hospital Regional Universitario de Málaga, 29011 Málaga, Spain.
  • Multidisciplinary Group for Paediatric Research, Instituto de Investigación Biomédica de Málaga (IBIMA), University of Málaga, 29010 Málaga, Spain.
  • Faculty of Medicine, University of Málaga, 29071 Málaga, Spain.
  • Service of Preventive Medicine and Public Health, Hospital Universitario San Cecilio, 18016 Granada, Spain.
  • Service of Paediatrics, Hospital Virgen del Rocío, 41013 Seville, Spain.
  • Service of Paediatrics, Hospital Regional Universitario de Málaga, 29010 Málaga, Spain.
  • Service of Paediatrics, Hospital Universitario Reina Sofia, 14004 Córdoba, Spain.
  • Service of Paediatric Infectious Diseases, Hospital Materno Infantil Infanta Leonor, Hospital Universitario Torrecárdenas, 04009 Almería, Spain.
  • Service of Paediatrics, Hospital Virgen Macarena, 41009 Seville, Spain.
  • Service of Paediatrics, Hospital Universitario de Jaén, 23007 Jaén, Spain.
  • Service of Paediatrics, Hospital Universitario Virgen de las Nieves, 18014 Granada, Spain.
  • Service of Paediatrics, Hospital Universitario Juan Ramón Jiménez, 21005 Huelva, Spain.
  • Service of Paediatrics, Hospital Universitario Puerta del Mar, 11009 Cádiz, Spain.
  • General Directorate of Public Health and Pharmaceutical Regulation, Ministry of Health and Consumer Affairs of the Regional Government of Andalusia, 41020 Seville, Spain.
  • Department of Preventive Medicine and Public Health, University of Granada, 18016 Granada, Spain.
  • Instituto de Investigación Biosanitaria de Granada (ibs.GRANADA), 18012 Granada, Spain.
  • Centros de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), 28029 Madrid, Spain.
  • Service of Surveillance and Occupational Health, General Directorate of Public Health and Pharmaceutical Regulation, Ministry of Health and Consumer Affairs of the Regional Government of Andalusia, 41020 Seville, Spain.

Abstract

BACKGROUND

Nirsevimab was indicated in a population level for all infants < 6 months during the 2023-2024 season in Andalusia (southern Spain). Our aim was to analyse the effect of nirsevimab in the reduction in complications in infants hospitalised for RSV bronchiolitis.

METHODS

A retrospective observational cohort study was conducted in nine relevant hospitals from all provinces of Andalusia, a region with over 9 million inhabitants. The study sample included 222 children, divided into two groups: infants administered with nirsevimab for passive immunisation (exposure) and infants not administered with nirsevimab. Clinical outcomes were analysed, including the use of respiratory support, the need for admission to paediatric intensive care unit (PICU), and duration of hospitalisation. Bivariate analyses were performed, and multivariable logistic regression models were designed to calculate adjusted odds ratios (ORa), and Cox regression models to calculate adjusted hazard ratios (HRa).

RESULTS

Bivariate analysis showed an association between passive immunisation with nirsevimab and a lower frequency of numerous outcomes. After adjustment for relevant covariates, multivariable models showed that the exposure (nirsevimab) reduced nasal cannula use by 64% (13-85%), invasive or non-invasive mechanical ventilation by 48% (1-73%), PICU admission by 54% (14-75%), length of hospitalisation by 30% (8-47%), and length of nasal cannula by 31% (7-49%). A higher risk of co-infection was observed in those immunised (aOR = 3.42, 95%CI: 1.52-7.68).

CONCLUSIONS

Passive immunisation with nirsevimab may decrease the severity of RSV bronchiolitis in infants requiring hospitalisation, thus contributing tertiary prevention that extends beyond the prevention of RSV infection.

MeSH

Respiratory Syncytial Viruses, Multiple Chronic Conditions, Viruses, Antibodies, Monoclonal, Bronchiolitis, Cannula, Infections, Tertiary Prevention, Infant

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