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

Development of a Methodology to Analyze Nasal Tissue-resident Memory Immune Cells and Peripheral Memory Cells Able to Migrate to Airway Tissues (MUCOVAC)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Nasal tissue-resident memory T and B cells; Device: Nasal fluid sampling; Device: Saliva sampling; Other: Blood sampling; Diagnostic test: ELISA; Diagnostic test: Neutralization test; Diagnostic test: ELISPot; Diagnostic test: Transcriptomics

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. .

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • Centre Hospitalier Universitaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FLOQSwab, Copan Diagnostics; Nasal cells are collected in both nostrils using one FLOQSwab per nostril	Device: Nasal tissue-resident memory T and B cells; Nasal tissue-resident memory T and B cells are quantified using flow cytometry.; Device: Nasal fluid sampling; Nasal fluid is collected using strip (Hunt Development) in both nostrils; Device: Saliva sampling; Saliva is collected using Oracol (Malvern Medical Developments); Other: Blood sampling; Isolation of peripheral blood mononuclear cells (PBMC) and serum from blood; Diagnostic test: ELISA; ELISA to measure antibody responses in mucosal fluids and blood; Diagnostic test: Neutralization test; Neutralization test to measure neutralizing antibody responses in mucosal fluids and blood to measure neutralizing antibody responses in mucosal fluids and blood; Diagnostic test: ELISPot; ELISPot to measure cellular responses in blood; Diagnostic test: Transcriptomics; Transcriptomics to quantify the gene expression of immunological markers in blood
Experimental: Rhino-Pro Curette, Arlington Scientific; Nasal cells are collected in both nostrils using one curette per nostril	Device: Nasal tissue-resident memory T and B cells; Nasal tissue-resident memory T and B cells are quantified using flow cytometry.; Device: Nasal fluid sampling; Nasal fluid is collected using strip (Hunt Development) in both nostrils; Device: Saliva sampling; Saliva is collected using Oracol (Malvern Medical Developments); Other: Blood sampling; Isolation of peripheral blood mononuclear cells (PBMC) and serum from blood; Diagnostic test: ELISA; ELISA to measure antibody responses in mucosal fluids and blood; Diagnostic test: Neutralization test; Neutralization test to measure neutralizing antibody responses in mucosal fluids and blood to measure neutralizing antibody responses in mucosal fluids and blood; Diagnostic test: ELISPot; ELISPot to measure cellular responses in blood; Diagnostic test: Transcriptomics; Transcriptomics to quantify the gene expression of immunological markers in blood
Experimental: Cervical brush, Microm Microtech; Nasal cells are collected in both nostrils using one brush per nostril	Device: Nasal tissue-resident memory T and B cells; Nasal tissue-resident memory T and B cells are quantified using flow cytometry.; Device: Nasal fluid sampling; Nasal fluid is collected using strip (Hunt Development) in both nostrils; Device: Saliva sampling; Saliva is collected using Oracol (Malvern Medical Developments); Other: Blood sampling; Isolation of peripheral blood mononuclear cells (PBMC) and serum from blood; Diagnostic test: ELISA; ELISA to measure antibody responses in mucosal fluids and blood; Diagnostic test: Neutralization test; Neutralization test to measure neutralizing antibody responses in mucosal fluids and blood to measure neutralizing antibody responses in mucosal fluids and blood; Diagnostic test: ELISPot; ELISPot to measure cellular responses in blood; Diagnostic test: Transcriptomics; Transcriptomics to quantify the gene expression of immunological markers in blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab	This outcome is measured by the three devices : FLOQSwab; Rhino-Pro Curette; Cervical brush	At inclusion, one month, two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequencies of resident memory T and B lymphocytes	Frequencies of resident memory T and B lymphocytes are measured by the three devices : FLOQSwab; Rhino-Pro Curette; Cervical brush	At inclusion, one month, two months
Expression levels of respiratory mucosal migration markers on peripheral memory lymphocytes	This outcome is measured by the three devices : FLOQSwab; Rhino-Pro Curette; Cervical brush	At inclusion, one month, two months
Visual analog scale for pain	Scale from 0 to 10 (0 = no pain, 10 = intolerable pain) This outcome is measured by the three devices : FLOQSwab; Rhino-Pro Curette; Cervical brush	At inclusion, one month, two months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Sanofi Pasteur, a Sanofi Company
• Investigators: Principal Investigator: Elisabeth BOTELHO-NEVERS, MD-PhD, CHU de Saint-Etienne; Study Director: STEPHANE PAUL, MD-PhD, CHU de Saint-Etienne; Study Chair: Stéphanie LONGUET, PhD, Université de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2024
• Primary Completion (Actual): November 11, 2024
• Study Completion (Actual): November 11, 2024

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: T cells; B cells; Nasal immune cells; sampling device; airway immunity; memory immune responses
• Other Study ID Numbers: 23CH294; 2024-A00255-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No