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

Centre Hospitalier Universitaire de Saint Etienne

Status and phase

Active, not recruiting

Phase 4

Conditions

Flu Vaccine

Volunteers

Treatments

Biological: Biological samples

Drug: Flu Vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06824779

2025-521217-46-00 (EU Trial (CTIS) Number)

24CH249

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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