Monitoring effectiveness of nirsevimab immunization against RSV hospitalization using surveillance data: a test-negative case-control study, Spain, October 2024-March 2025.

Effectiveness of nirsevimab against respiratory syncytial virus (RSV) hospitalization during the 2024/2025 season in Spain was estimated using a test-negative design (TND) and hospital-based respiratory infections surveillance data. Children born between 1 April 2024 and 31 March 2025 and hospitaliz...

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Detalles Bibliográficos
Autores: Campos Mena, Sandra, Pérez-Gimeno, Gloria, Lorusso, Nicola, Álvarez Río, Virginia, Basile, Luca, Batalla Rebollo, Noa, García-Comas, Luis, Andreu Ivorra, Blanca, Pérez-Panadés, Jordi, Ramos Marín, Violeta, Castrillejo, Daniel, Fernández Ibáñez, Ana, Rafael de la Cruz López, María Ángeles, Nuñez, Olivier, Monge Corella, Susana, Grupo SiVIRA de vigilancia y efectividad vacunal en España
Tipo de recurso: artículo
Fecha de publicación:2025
País:España
Institución:Instituto de Salud Carlos III (ISCIII)
Repositorio:Repisalud
Idioma:inglés
OAI Identifier:oai:dnet:repisalud__::22a7e950f845cca391fbb9fe5ed7e4f0
Acceso en línea:https://hdl.handle.net/20.500.12105/27328
Access Level:acceso abierto
Palabra clave:Immunization
Infant
Nirsevimab
Respiratory syncytial virus
Surveillance system
Test-negative design
Antibodies, Monoclonal, Humanized
Antiviral Agents
Case-Control Studies
Child, Preschool
Female
Hospitalization
Humans
Infant, Newborn
Male
Respiratory Syncytial Virus Infections
Respiratory Syncytial Virus, Human
Spain
Descripción
Sumario:Effectiveness of nirsevimab against respiratory syncytial virus (RSV) hospitalization during the 2024/2025 season in Spain was estimated using a test-negative design (TND) and hospital-based respiratory infections surveillance data. Children born between 1 April 2024 and 31 March 2025 and hospitalized with severe respiratory infection between the start of the 2024 immunization campaign (regionally variable, between 16 September and 1 October 2024) and 31 March 2025 were systematically RT-PCR RSV-tested within 10 days of symptom onset and classified as cases if positive or controls if negative. Nirsevimab effectiveness ((1 - odds ratio) × 100) was estimated using logistic regression, adjusted for admission week, age, sex, high-risk factors, and regional RSV hospitalization rate. We included 199 cases (68.8% immunized) and 360 controls (86.4% immunized). Overall effectiveness was 65.5% (95% confidence interval: 45.2 to 78.3). Effectiveness was similar among infants born before and after the campaign start (63.6% vs. 70.4%, respectively). We found an unexpected early decrease in effectiveness with increasing time since immunization and age, albeit with wide confidence intervals for some groups. Strong age-period-cohort effects and potential sources of bias were identified, highlighting the need to further explore methodological challenges of implementing the TND in the dynamic population of newborns.

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