ENVIEANCILLAIRE: Efficacy of Nirsevimab in Children Hospitalised With RSV Bronchiolitis - A Subsidiary Study on the Immune Signature and Microbial Environment (ENVIEANCILLAIR)

Among children aged ≤ 6 months included in the ENVIE study, the ENVIE_ancillaire study will be offered to cases of RSV infection or to controls. The study involves a nasopharyngeal swab using a FLOQ-SWAB™ swab and a fingertip sample (dextro type). These samples will be collected specifically for the purpose of studying immunity.

A blood sample may also be requested for children weighing ≥5 kg who are included in the ENVIE_ancillaire study. The purpose of this sample collection will be to conduct an advanced immunological study

Study Overview

• Status: Recruiting
• Conditions: Mucosal Cytokine Profile of Patients (Type I and III Interferons, Pro-inflammatory Cytokines)
• Intervention / Treatment: Biological: a study of the mucosal immune signature associated with hospitalised RSV bronchiolitis

Detailed Description

Among children aged ≤ 6 months included in the ENVIE study, the ENVIE_ancillaire study will be offered to cases of RSV infection or to controls. The study involves a nasopharyngeal swab using a FLOQ-SWAB™ swab and a fingertip sample (dextro type). This sample collection will be carried out specifically for the study of immunity. Innate immune mediators (type I, II and III IFNs) and key inflammatory molecules (IL-6, TNF-alpha, IL-10) will be quantified, and adaptive immunity will be analysed by measuring local immunoglobulin titres (IgG, A, M, subclasses and specific antibodies against the inactivated virus) from the nasopharyngeal swab and blood samples absorbed onto filter paper. A blood sample may also be offered to children weighing ≥5 kg who are included in the ENVIE_ancillaire study. The purpose of this sample collection will be to conduct an advanced immunological study (identification of the host's protein, cellular and transcriptomic response). Finally, the bacterial microbiome (16S RNA) and the soluble virome will be characterised by high-throughput sequencing.

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Julie TOUBIANA, PhD; Phone Number: 01 44 49 57 44; Email: julie.toubiana@aphp.fr
• Study Contact Backup: Name: Camille JUNG, PhD; Phone Number: 0157022268; Email: camille.jung@chicreteil.fr

Study Locations

• France
  • Créteil, France
    • Recruiting
    • CHI Créteil
    • Contact: Mickaël SHUM
  • Paris, France
    • Recruiting
    • CHU Robert-Debré
    • Contact: Naïm OULDALI, phD
  • Paris, France
    • Recruiting
    • CHU Necker
    • Contact: Julie TOUBIANA, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Among children aged 6 months or younger included in the ENVIE study, the ENVIE_ancillaire study will be offered to those with RSV infection or to the control group.

Description

Inclusion Criteria:

• Written consent to take part in the study
• Registered with a social security scheme

Cases:

• Children aged 6 months or under included in the ENVIE study. Treated for bronchiolitis caused by RSV
• Admitted to hospital following a visit to the paediatric A&E department

Control group:

Children aged 6 months or under included in the ENVIE study. Admitted to a standard ward or a Short-Stay Unit, or having attended the paediatric A&E department

For one of the following reasons:

• Febrile urinary tract infection, without acute ENT or respiratory symptoms
• Acute gastroenteritis, without acute ENT or respiratory symptoms
• Infant colic without fever, without ENT or acute respiratory condition
• Weight stagnation or feeding difficulties without fever, without acute ENT or respiratory symptoms
• Neonatal jaundice without fever, without acute ENT or respiratory symptoms
• Unexplained crying without fever, without acute ENT or respiratory symptoms
• Head injury, without acute ENT or respiratory symptoms
• Admitted for acute surgical conditions, without fever, without acute ENT or respiratory symptoms
• Nappy rash, without fever, without acute ENT or respiratory symptoms
• Fracture, without fever, without acute ENT or respiratory symptoms.

Exclusion Criteria:

• Refusal to participate by the legal representative
• Administration of palivizumab
• Maternal vaccination against RSV.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case; Children aged 6 months or under included in the ENVIE study, treated for bronchiolitis caused by RSV	Biological: a study of the mucosal immune signature associated with hospitalised RSV bronchiolitis; Once those with parental authority have confirmed their willingness for their child to take part in the research and written consent has been obtained, the following samples may be collected: A nasopharyngeal swab; A 'dextro' blood sample with a blot on filter paper. The nasopharyngeal samples and blotting papers will be stored at -20°C (or -80°C if possible) and transported to the Pasteur Institute as soon as possible (just-in-time). il sera possible de proposer un prélèvement supplémentaire dans le cadre d'une étude immunologique avancée, chez les nourrissons ≥ 5 kg. Ce prélèvement comprend : Un tube hépariné pour plasmatèque et cellulotèque : 5 mL; Un tube PAX gene pediatrique pour RNAtèque : 0,5 mL
Control group; Children aged 6 months or under included in the ENVIE study, admitted to a standard ward or a Short-Stay Unit, or who have attended the paediatric A&E department For one of the following reasons: Febrile urinary tract infection, without acute ENT or respiratory symptoms; Acute gastroenteritis, without acute ENT or respiratory symptoms; Infant colic without fever, without ENT or; Weight stagnation or feeding difficulties without fever, without acute ENT or respiratory symptoms; Neonatal jaundice without fever, without acute ENT or respiratory symptoms; Unexplained crying without fever, without acute ENT or respiratory symptoms; Head injury, without acute ENT or respiratory symptoms; Treated for an acute surgical condition, without fever, without acute ENT or respiratory symptoms; Nappy rash, without fever, without acute ENT or respiratory symptoms,; Fracture, without fever, without acute ENT or respiratory symptoms.	Biological: a study of the mucosal immune signature associated with hospitalised RSV bronchiolitis; Once those with parental authority have confirmed their willingness for their child to take part in the research and written consent has been obtained, the following samples may be collected: A nasopharyngeal swab; A 'dextro' blood sample with a blot on filter paper. The nasopharyngeal samples and blotting papers will be stored at -20°C (or -80°C if possible) and transported to the Pasteur Institute as soon as possible (just-in-time). il sera possible de proposer un prélèvement supplémentaire dans le cadre d'une étude immunologique avancée, chez les nourrissons ≥ 5 kg. Ce prélèvement comprend : Un tube hépariné pour plasmatèque et cellulotèque : 5 mL; Un tube PAX gene pediatrique pour RNAtèque : 0,5 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mucosal cytokine profile of patients (type I and III interferons, pro-inflammatory cytokines)	Baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2024
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 5, 2026

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024-A01208-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No