Analyzes of Nasal Tissue-resident Memory Immune Cells and Peripheral Memory Cells Able to Migrate to Airway Tissues (MUCOVAC)

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Healthy Volunteers

Treatments: Diagnostic Test: ELISPot; Device: Nasal fluid sampling; Device: Saliva sampling; Diagnostic Test: Transcriptomics; Diagnostic Test: Neutralization test; Diagnostic Test: ELISA; Other: Blood sampling; Device: Nasal tissue-resident memory T and B cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06469359

23CH294

2024-A00255-42 (Other Identifier)

Details and patient eligibility

About

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.

Full 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. .

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

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 3 patient groups

FLOQSwab, Copan Diagnostics

Experimental group

Description:

Nasal cells are collected in both nostrils using one FLOQSwab per nostril

Treatment:

Device: Nasal tissue-resident memory T and B cells

Other: Blood sampling

Diagnostic Test: ELISA

Diagnostic Test: Neutralization test

Diagnostic Test: Transcriptomics

Device: Saliva sampling

Device: Nasal fluid sampling

Diagnostic Test: ELISPot

Rhino-Pro Curette, Arlington Scientific

Experimental group

Description:

Nasal cells are collected in both nostrils using one curette per nostril

Treatment:

Device: Nasal tissue-resident memory T and B cells

Other: Blood sampling

Diagnostic Test: ELISA

Diagnostic Test: Neutralization test

Diagnostic Test: Transcriptomics

Device: Saliva sampling

Device: Nasal fluid sampling

Diagnostic Test: ELISPot

Cervical brush, Microm Microtech

Experimental group

Description:

Nasal cells are collected in both nostrils using one brush per nostril

Treatment:

Device: Nasal tissue-resident memory T and B cells

Other: Blood sampling

Diagnostic Test: ELISA

Diagnostic Test: Neutralization test

Diagnostic Test: Transcriptomics

Device: Saliva sampling

Device: Nasal fluid sampling

Diagnostic Test: ELISPot