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Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2026

Genomic surveillance of respiratory syncytial virus during 2023/2024 nirsevimab prophylaxis, Eastern Spain, early results.

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Mengual-Chuliá Beatriz, Launes Cristian, Cazorla Elena, López-Lacort Mónica, Muñoz-Quiles Cintia, Mira-Iglesias Ainara, Agüera Marta, Penela-Sánchez Daniel, Garcés-Sánchez María, Fernández-García Carlos, Cervera Héctor, Carballido-Fernández Mario, Pineda-Caplliure Ana, Mollar-Maseres Juan, Shalabi-Benavent Maruan, Sanz-Herrero Francisco, Díez-Domingo Javier, Muñoz-Almagro Carmen, Orrico-Sánchez Alejandro, López-Labrador F Xavier, MEDIPRIM and VAHNSI Networks

Аннотация

OBJECTIVES: Nirsevimab is a recombinant monoclonal antibody used to prevent lower respiratory tract infections caused by respiratory syncytial virus (RSV) in infants aged <1 year. In Spain, a universal immunization programme for all children aged <1 year has been in place since October 2023. Our goal was to detect potential changes in the viral F protein related to nirsevimab prophylaxis.

METHODS: We conducted whole-genome sequencing of 68 RSV isolates from both outpatient (n = 24) and inpatient (n = 59) infants aged <1 year, immunized (n = 42) or not (n = 41) with nirsevimab, during the 2023/2024 season in Eastern Spain.

RESULTS: The distribution of RSV clades and amino acid substitutions at nirsevimab binding sites on the F protein was as follows (nirsevimab recipients vs. nonrecipients): A.D.1 (35.71% [n = 15] vs. 41.46% [n = 17]), A.D.3 (9.52% [n = 4] vs. 19.51% [n = 8]), A.D.5 (16.66% [n = 7] vs. 7.32% [n = 3]), and B.D.E.1 (9.52% [n = 4] vs. 24.39% [n = 10]). Primary care versus inpatient distributions were A.D.1 (29.17% [n = 7] vs. 42.40% [n = 25]), A.D.3 (0% [n = 0] vs. 20.34% [n = 12]), A.D.5 (4.17% [n = 1] vs. 15.25% [n = 9]), and B.D.E.1 (8.33% [n = 2] vs. 20.34% [n = 12]). Small numbers precluded meaningful statistical comparisons. Only two clade A.D.3 isolates of 68 RSV-A viruses showed mutations/substitutions at nirsevimab binding sites on the F protein, one of them from a nirsevimab recipient. For RSV-B, all isolates were clade B.D.E.1 carrying three substitutions at nirsevimab binding sites (I206M + Q209 + S211N), regardless of nirsevimab immunization status or care setting.

CONCLUSIONS: Our study presents data from Spain showing that the selection of nirsevimab resistance mutations has not emerged as a significant concern during the first passive immunization season, in line with other reports from France, the United States, and Australia. Genome characterization of RSV will be useful for monitoring immune prophylaxis campaigns and the emergence of potential resistance in the future.

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

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