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Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
Hospitalization for RSV lower respiratory tract infections (LRTI) still occurs, including in infants having received nirsevimab/clesrovimab or born to mothers vaccinated with Abrysvo. We hypothesize that pediatric patients hospitalized for RSV LRTIs occurring in the era of large use of prophylaxis, could be, at least in part, explained by virological factors (emergence/selection of variants with decreased susceptibility to prophylaxis) and/or immunological factors (inherited immune deficiency, presence of auto-antibodies neutralizing anti-viral cytokines such as type I interferons, impaired mucosal responses or mucosal pharmacokinetics issues inducing low levels of local concentrations of nirsevimab/clesrovimab).
Key Details
Gender
All
Age Range
Any - 24 Months
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2026-11-15
Completion Date
2028-12-15
Last Updated
2026-10-26
Healthy Volunteers
No
Interventions
Prior exposure to prophylactic treatment with Abrysvo or nirsevimab/clesrovimab
Being born to a woman having received Abrysvo vaccine ≥ 14 days before delivery (thus, children born to mothers vaccinated \<14 days before delivery will be considered as "unexposed" to Abrysvo) AND being less than 12 months of age at the time of admission for RSV LRTI OR having received nirsevimab or clesrovimab ≥ 7 days and \< 12 months before admission for RSV LRTI (thus, children admitted \< 7 days after nirsevimab/clesrovimab administration will be considered as "unexposed" to nirsevimab/clesrovimab).
Non-exposure to prior prophylactic treatment
all other children will be considered as non-exposed to prophylaxis
Locations (1)
Hôpital Necker - Enfants Malades
Paris, France