Impact of FLU Vaccination on Nasal Resident Memory Immune Responses and Peripheral Respiratory-tr… (NCT06824779) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Impact of FLU Vaccination on Nasal Resident Memory Immune Responses and Peripheral Respiratory-tropic Memory Immune Responses
France30 participantsStarted 2025-12-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab
Timeframe: one month post vaccination
Trial details
NCT IDNCT06824779
SponsorCentre Hospitalier Universitaire de Saint Etienne