Clinical trial NCT06469359: Analyzes of Nasal Tissue-resident Memory Immune Cells and Peripheral Memory Cells Able to Migrate to Airway Tissues (MUCOVAC)
Official title: Development of a Methodology to Analyze Nasal Tissue-resident Memory Immune Cells and Peripheral Memory Cells Able to Migrate to Airway Tissues (MUCOVAC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Nasal immune cells
sampling device
airway immunity
memory immune responses
T cells
B cells
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Sanofi Pasteur, a Sanofi Company
First posted: 2024-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective study in healthy volunteers. Randomized, single-blind, cross-over trial
Primary purpose: DIAGNOSTIC

Brief summary: Clinical evaluation of vaccines against respiratory viruses is currently based on the analysis of systemic immune responses, whereas respiratory immunity is the first line of defense against respiratory pathogens. In addition to secretory immunoglobulin A (IgA) in mucosal fluids which are essential to neutralize the pathogens at mucosal surfaces, tissue-resident memory immune cells have been shown to be crucial in protection. Furthermore, memory immune cells in blood able to migrate to airway tissues also play a crucial role. Airway immune responses have not been studied a lot due to the lack of a standardized methodology to evaluate them in humans.

Detailed description: The goal of this study is to develop a methodology to collect and analyze nasal tissue-resident memory T and B cells and to evaluate peripheral memory T and B cells expressing airway homing markers in healthy volunteers. Three devices for nasal cell sampling will be compared. Tissue-resident and peripheral memory immune responses will be determined using flow cytometry and correlated with humoral and cellular responses, as well as with gene expression at mucosal and systemic levels. .

Eligibility criteria: Inclusion Criteria:

* Affiliated to the Social Security System
* Signed informed consent form

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
* 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

Primary outcomes:
measure: Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab
timeFrame: At inclusion, one month, two months
Secondary outcomes:
measure: Frequencies of resident memory T and B lymphocytes
timeFrame: At inclusion, one month, two months
measure: Expression levels of respiratory mucosal migration markers on peripheral memory lymphocytes
timeFrame: At inclusion, one month, two months
measure: Visual analog scale for pain
timeFrame: At inclusion, one month, two months
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: CHU DE SAINT-ETIENNE
name: ELISABETH BOTELHO-NEVERS, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Saint-Etienne
name: STEPHANE PAUL, MD-PhD
role: STUDY_DIRECTOR
affiliation: Université de Saint-Etienne
name: STEPHANIE LONGUET, PhD
role: STUDY_CHAIR
References: