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

December 16, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab
Time Frame: At inclusion, one month, two months

This outcome is measured by the three devices :

  • FLOQSwab
  • Rhino-Pro Curette
  • Cervical brush
At inclusion, one month, two months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequencies of resident memory T and B lymphocytes
Time Frame: At inclusion, one month, two months

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
Time Frame: At inclusion, one month, two months

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
Time Frame: At inclusion, one month, two months

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi Pasteur, a Sanofi Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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