Impact of FLU Vaccination on Nasal Resident Memory Immune Responses and Peripheral Respiratory-tropic Memory Immune Responses (MUCOVAC_2)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Volunteers; Flu Vaccine
• Intervention / Treatment: Drug: Flu Vaccine; Biological: Biological samples

Detailed Description

An initial MUCOVAC clinical trial (NCT06469359), sponsored by the CHU of Saint-Etienne and in collaboration with Jean Monnet University (GROUPE ON MUCOSAL IMMUNITY AND PATHOGENS (GIMAP)) has made it possible to set up a methodology for collecting and analysis of nasal resident memory T and B lymphocytes, and to detect peripheral memory lymphocytes that have the capacity to migrate into respiratory tissues. In this randomized cross-over study, the investigators investigators compared three nasal cell harvesting devices in a cohort of a cohort of healthy volunteers: (i) a nylon swab (FlowSwab, Copan Diagnostics), (ii) a plastic curette (Rhino-pro curette, Arlington Scientifc) and (iii) a mini cytological brush (Microm Microtech). This study determined that the nylon swab (data not yet published) is the most to collect viable memory resident lymphocytes from the nasal sphere.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Chu de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• Individuals experiencing respiratory infection symptoms. Inclusion will be postponed up to 7 days after the symptom resolution
• People with no command of the French language

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FLU VACCINATION; Flu vaccination by one of FLU vaccines in the french market : FluarixTetra® (GSK), VaxigripTetra® (Sanofi-Pasteur), Influvac Tetra® (VIATRIS MEDICAL)	Drug: Flu Vaccine; Vaccination against FLU by one of FLU vaccines in the french market; Biological: Biological samples; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab	one month post vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Sanofi Pasteur, a Sanofi Company
• Investigators: Principal Investigator: Elisabeth BOTELHO-NEVERS, MD-PhD, Chu de Saint-Etienne; Study Chair: Stéphanie LONGUET, PhD, Université de Saint-Etienne; Study Director: Stéphane PAUL, PhD, Chu de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2025
• Primary Completion (Actual): December 19, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 13, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Flu Vaccine; Nasal immune cells; airway immunity; memory immune responses
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; Influenza Vaccines
• Other Study ID Numbers: 24CH249; 2025-521217-46-00 (Ctis)

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
• product manufactured in and exported from the U.S.: No