VolunteersPhase 4MUCOVAC_2NCT06824779
Impact of FLU Vaccination on Nasal Resident Memory Immune Responses and Peripheral Respiratory-tropic Memory Immune Responses
A Phase 4 study testing Flu Vaccine and Biological samples in people with Volunteers and Flu Vaccine, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Volunteers, Flu Vaccine
- What is being tested?
- Flu Vaccine and Biological samples
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2025to Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Affiliated to the Social Security System
- Signed informed consent form
- Having decided to be vaccinated against the flu
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Volunteers, Flu Vaccine
- Being tested
- Flu Vaccine, Biological samples
- Keywords
- Flu Vaccine, Nasal immune cells, airway immunity, memory immune responses
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu VaccineDrug
Vaccination against FLU by one of FLU vaccines in the french market
Biological samplesBiological
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
| Study group | Role | What they receive |
|---|---|---|
| FLU VACCINATION | Experimental | Flu vaccination by one of FLU vaccines in the french market : FluarixTetra® (GSK), VaxigripTetra® (Sanofi-Pasteur), Influvac Tetra® (VIATRIS MEDICAL) Receives: Drug: Flu Vaccine; Biological: Biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab
Measured: one month post vaccination
Secondary outcomes (2)
Frequencies of resident memory T and B lymphocytes
Measured: one month post vaccination
Expression levels of respiratory mucosal migration markers on peripheral memory lymphocytes
Measured: one month post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start5 Dec 2025
- Primary completion19 Dec 2025
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VolunteersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Stéphane PAUL, PhD, Study director, CHU de Saint-EtienneStéphanie LONGUET, PhD, Study chair, Université de Saint-EtienneElisabeth BOTELHO-NEVERS, MD-PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824779
- Sponsor's protocol ID
- 24CH249
- Other IDs
- 2025-521217-46-00, 2025
- Acronym
- MUCOVAC_2
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Influenza Vaccination on Nasal Resident Memory Immune Responses and Peripheral Respiratory-tropic Memory Immune Responses
- ClinicalTrials.gov ID
- NCT06824779
- Acronym / sponsor ID
- MUCOVAC_2 / 24CH249
- Conditions
- Volunteers, Flu Vaccine
- Keywords
- Flu Vaccine, Nasal immune cells, airway immunity, memory immune responses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- Mar 2026 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLU VACCINATION | Experimental | Drug: Flu Vaccine, Biological: Biological samplesFlu vaccination by one of FLU vaccines in the french market : FluarixTetra® (GSK), VaxigripTetra® (Sanofi-Pasteur), Influvac Tetra® (VIATRIS MEDICAL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Affiliated to the Social Security System
- Signed informed consent form
- Having decided to be vaccinated against the flu
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flu VaccineVaccination against FLU by one of FLU vaccines in the french market | Drug | FLU VACCINATION |
| Biological samplesBefore 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 | Biological | FLU VACCINATION |
Primary outcome
Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab
Time frame: one month post vaccination
2 secondary outcomes
Frequencies of resident memory T and B lymphocytes
Time frame: one month post vaccination
Expression levels of respiratory mucosal migration markers on peripheral memory lymphocytes
Time frame: one month post vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane PAUL, PhD study director
CHU de Saint-Etienne
Stéphanie LONGUET, PhD study chair
Université de Saint-Etienne
Elisabeth BOTELHO-NEVERS, MD-PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flu Vaccine and Biological samples in people with Volunteers and Flu Vaccine, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab (time frame: one month post vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.