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

NCT ID: NCT06469359

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-22

Study Completion Date

2024-11-11

Brief Summary

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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

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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. .

Conditions

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Healthy Volunteers

Keywords

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Nasal immune cells sampling device airway immunity memory immune responses T cells B cells

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Prospective study in healthy volunteers. Randomized, single-blind, cross-over trial
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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FLOQSwab, Copan Diagnostics

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

Group Type EXPERIMENTAL

Nasal tissue-resident memory T and B cells

Intervention Type DEVICE

Nasal tissue-resident memory T and B cells are quantified using flow cytometry.

Nasal fluid sampling

Intervention Type DEVICE

Nasal fluid is collected using strip (Hunt Development) in both nostrils

Saliva sampling

Intervention Type DEVICE

Saliva is collected using Oracol (Malvern Medical Developments)

Blood sampling

Intervention Type OTHER

Isolation of peripheral blood mononuclear cells (PBMC) and serum from blood

ELISA

Intervention Type DIAGNOSTIC_TEST

ELISA to measure antibody responses in mucosal fluids and blood

Neutralization test

Intervention Type DIAGNOSTIC_TEST

Neutralization test to measure neutralizing antibody responses in mucosal fluids and blood to measure neutralizing antibody responses in mucosal fluids and blood

ELISPot

Intervention Type DIAGNOSTIC_TEST

ELISPot to measure cellular responses in blood

Transcriptomics

Intervention Type DIAGNOSTIC_TEST

Transcriptomics to quantify the gene expression of immunological markers in blood

Rhino-Pro Curette, Arlington Scientific

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

Group Type EXPERIMENTAL

Nasal tissue-resident memory T and B cells

Intervention Type DEVICE

Nasal tissue-resident memory T and B cells are quantified using flow cytometry.

Nasal fluid sampling

Intervention Type DEVICE

Nasal fluid is collected using strip (Hunt Development) in both nostrils

Saliva sampling

Intervention Type DEVICE

Saliva is collected using Oracol (Malvern Medical Developments)

Blood sampling

Intervention Type OTHER

Isolation of peripheral blood mononuclear cells (PBMC) and serum from blood

ELISA

Intervention Type DIAGNOSTIC_TEST

ELISA to measure antibody responses in mucosal fluids and blood

Neutralization test

Intervention Type DIAGNOSTIC_TEST

Neutralization test to measure neutralizing antibody responses in mucosal fluids and blood to measure neutralizing antibody responses in mucosal fluids and blood

ELISPot

Intervention Type DIAGNOSTIC_TEST

ELISPot to measure cellular responses in blood

Transcriptomics

Intervention Type DIAGNOSTIC_TEST

Transcriptomics to quantify the gene expression of immunological markers in blood

Cervical brush, Microm Microtech

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

Group Type EXPERIMENTAL

Nasal tissue-resident memory T and B cells

Intervention Type DEVICE

Nasal tissue-resident memory T and B cells are quantified using flow cytometry.

Nasal fluid sampling

Intervention Type DEVICE

Nasal fluid is collected using strip (Hunt Development) in both nostrils

Saliva sampling

Intervention Type DEVICE

Saliva is collected using Oracol (Malvern Medical Developments)

Blood sampling

Intervention Type OTHER

Isolation of peripheral blood mononuclear cells (PBMC) and serum from blood

ELISA

Intervention Type DIAGNOSTIC_TEST

ELISA to measure antibody responses in mucosal fluids and blood

Neutralization test

Intervention Type DIAGNOSTIC_TEST

Neutralization test to measure neutralizing antibody responses in mucosal fluids and blood to measure neutralizing antibody responses in mucosal fluids and blood

ELISPot

Intervention Type DIAGNOSTIC_TEST

ELISPot to measure cellular responses in blood

Transcriptomics

Intervention Type DIAGNOSTIC_TEST

Transcriptomics to quantify the gene expression of immunological markers in blood

Interventions

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Nasal tissue-resident memory T and B cells

Nasal tissue-resident memory T and B cells are quantified using flow cytometry.

Intervention Type DEVICE

Nasal fluid sampling

Nasal fluid is collected using strip (Hunt Development) in both nostrils

Intervention Type DEVICE

Saliva sampling

Saliva is collected using Oracol (Malvern Medical Developments)

Intervention Type DEVICE

Blood sampling

Isolation of peripheral blood mononuclear cells (PBMC) and serum from blood

Intervention Type OTHER

ELISA

ELISA to measure antibody responses in mucosal fluids and blood

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

ELISPot

ELISPot to measure cellular responses in blood

Intervention Type DIAGNOSTIC_TEST

Transcriptomics

Transcriptomics to quantify the gene expression of immunological markers in blood

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ELISABETH BOTELHO-NEVERS, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

CHU DE SAINT-ETIENNE

STEPHANE PAUL, MD-PhD

Role: STUDY_DIRECTOR

CHU de Saint-Etienne

STEPHANIE LONGUET, PhD

Role: STUDY_CHAIR

Université de Saint-Etienne

Locations

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Centre Hospitalier Universitaire

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2024-A00255-42

Identifier Type: OTHER

Identifier Source: secondary_id

23CH294

Identifier Type: -

Identifier Source: org_study_id