Impact of FLU Vaccination on Nasal Resident Memory Immune Responses and Peripheral Respiratory-tropic Memory Immune Responses

NCT06824779 | Active Not Recruiting Phase 4

• 2 other identifiers: 24CH2492025-521217-46-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Mucosal sites, such as respiratory mucosa, are the primary entry points entry points for pathogens. However, clinical evaluation of vaccines against respiratory respiratory pathogens is currently based primarily on analysis of systemic, i.e. peripheral antibody and cellular responses. These measurements give little indication of the immune responses in respiratory tissues tissues, even though the latter are essential for protection against infection. Protective immune responses in mucous membranes, including respiratory including respiratory tissues, rely on secretory IgA to neutralize pathogens neutralization of pathogens on the mucosal surface, as well as the development of the development of cellular responses, notably those from T (Trm) and B (Brm) lymphocytes. Preclinical studies and a few human studies have demonstrated that Trm are a crucial element mucosal protection against viral and bacterial infections. In fact it has been shown that resident memory lymphocytes, including Trm, are able to able to reside in nasal, pulmonary, intestinal, genital and skin mucosa and skin after infection.

Conditions

Volunteers; Flu Vaccine

Keywords

Flu Vaccine; Nasal immune cells; airway immunity; memory immune responses

Outcome Measures

Primary Outcomes (1)

• Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab

  one month post vaccination

Secondary Outcomes (2)

• Frequencies of resident memory T and B lymphocytes

  one month post vaccination

• Expression levels of respiratory mucosal migration markers on peripheral memory lymphocytes

  one month post vaccination

Study Arms (1)

FLU VACCINATION

EXPERIMENTAL

Flu vaccination by one of FLU vaccines in the french market : FluarixTetra® (GSK), VaxigripTetra® (Sanofi-Pasteur), Influvac Tetra® (VIATRIS MEDICAL)

Drug: Flu Vaccine; Biological: Biological samples

Interventions

Flu Vaccine DRUG

Vaccination against FLU by one of FLU vaccines in the french market

FLU VACCINATION

Biological samples BIOLOGICAL

Before and after the FLU vaccination, according the french recommendations, the following samples will be collected : Nasal fluid sampling Saliva sampling Blood samples Nasal cell sampling

FLU VACCINATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Affiliated to the Social Security System
• Signed informed consent form
• Having decided to be vaccinated against the flu

You may not qualify if:

• History of recurrent nosebleeds or systemic hemorrhages
• Previous injury or surgery which modified nasal cavity (e.g. deviated nasal septum)
• Individuals receiving anticoagulant therapy
• Individuals who experienced a severe respiratory infection leading to hospitalization in the last 6 months
• Individuals who received an antibiotic therapy for respiratory infection or any other infection in the last 6 months
• Immunocompromised individuals, or individuals taking immunosuppressed therapy or having a pathology (chronic infection, auto-immune disease) which could impact on immunity based on investigator's opinion
• Allergy to any component of the vaccines used in the study
• Unstable chronic pathology
• People deprived of liberty or hospitalized without any consent
• People under guardianship (authorship or curators)
• Individuals who received a vaccine (any vaccine) in the last 30 days
• Pregnant or breast-feeding people
• People with no command of the French language

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: collaborator
• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Stéphane PAUL, PhD

  CHU de Saint-Etienne

  STUDY DIRECTOR

• Stéphanie LONGUET, PhD

  Université de Saint-Etienne

  STUDY CHAIR

• Elisabeth BOTELHO-NEVERS, MD-PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: February 13, 2025
• Study Start: December 5, 2025
• Primary Completion: December 19, 2025
• Study Completion: March 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)