Healthy VolunteersMUCOVACNCT06469359
Analyzes of Nasal Tissue-resident Memory Immune Cells and Peripheral Memory Cells Able to Migrate to Airway Tissues (MUCOVAC)
A study testing Nasal tissue-resident memory T and B cells, Nasal fluid sampling and Saliva sampling in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Nasal tissue-resident memory T and B cells, Nasal fluid sampling and Saliva sampling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2024to 11 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Affiliated to the Social Security System
- Signed informed consent form
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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. .
- Conditions
- Healthy Volunteers
- Being tested
- Nasal tissue-resident memory T and B cells, Nasal fluid sampling, Saliva sampling, Blood sampling, ELISA
- Keywords
- Nasal immune cells, sampling device, airway immunity, memory immune responses, T cells, B cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal tissue-resident memory T and B cellsDevice
Nasal tissue-resident memory T and B cells are quantified using flow cytometry.
Nasal fluid samplingDevice
Nasal fluid is collected using strip (Hunt Development) in both nostrils
Saliva samplingDevice
Saliva is collected using Oracol (Malvern Medical Developments)
Blood samplingOther
Isolation of peripheral blood mononuclear cells (PBMC) and serum from blood
ELISADiagnostic test
ELISA to measure antibody responses in mucosal fluids and blood
Neutralization testDiagnostic test
Neutralization test to measure neutralizing antibody responses in mucosal fluids and blood to measure neutralizing antibody responses in mucosal fluids and blood
ELISPotDiagnostic test
ELISPot to measure cellular responses in blood
TranscriptomicsDiagnostic test
Transcriptomics to quantify the gene expression of immunological markers in blood
| Study group | Role | What they receive |
|---|---|---|
| FLOQSwab, Copan Diagnostics | Experimental | Nasal cells are collected in both nostrils using one FLOQSwab per nostril Receives: 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 |
| Rhino-Pro Curette, Arlington Scientific | Experimental | Nasal cells are collected in both nostrils using one curette per nostril Receives: 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 |
| Cervical brush, Microm Microtech | Experimental | Nasal cells are collected in both nostrils using one brush per nostril Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At inclusion, one month, two months
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: At inclusion, one month, two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start22 Jul 2024
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective study in healthy volunteers. Randomized, single-blind, cross-over trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- ELISABETH BOTELHO-NEVERS, MD-PhD, Principal investigator, CHU DE SAINT-ETIENNESTEPHANE PAUL, MD-PhD, Study director, CHU de Saint-EtienneSTEPHANIE LONGUET, PhD, Study chair, Université de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469359
- Sponsor's protocol ID
- 23CH294
- Other IDs
- 2024-A00255-42
- Acronym
- MUCOVAC
- Status last verified
- Dec 2024
- First submitted
- 17 Jun 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06469359
- Acronym / sponsor ID
- MUCOVAC / 23CH294
- Conditions
- Healthy Volunteers
- Keywords
- Nasal immune cells, sampling device, airway immunity, memory immune responses, T cells, B cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prospective study in healthy volunteers. Randomized, single-blind, cross-over trial
| Arm | Type | Receives |
|---|---|---|
| FLOQSwab, Copan Diagnostics | Experimental | 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: TranscriptomicsNasal cells are collected in both nostrils using one FLOQSwab per nostril |
| Rhino-Pro Curette, Arlington Scientific | Experimental | 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: TranscriptomicsNasal cells are collected in both nostrils using one curette per nostril |
| Cervical brush, Microm Microtech | Experimental | 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: TranscriptomicsNasal cells are collected in both nostrils using one brush per nostril |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Affiliated to the Social Security System
- Signed informed consent form
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal tissue-resident memory T and B cellsNasal tissue-resident memory T and B cells are quantified using flow cytometry. | Device | Cervical brush, Microm Microtech, FLOQSwab, Copan Diagnostics, Rhino-Pro Curette, Arlington Scientific |
| Nasal fluid samplingNasal fluid is collected using strip (Hunt Development) in both nostrils | Device | Cervical brush, Microm Microtech, FLOQSwab, Copan Diagnostics, Rhino-Pro Curette, Arlington Scientific |
| Saliva samplingSaliva is collected using Oracol (Malvern Medical Developments) | Device | Cervical brush, Microm Microtech, FLOQSwab, Copan Diagnostics, Rhino-Pro Curette, Arlington Scientific |
| Blood samplingIsolation of peripheral blood mononuclear cells (PBMC) and serum from blood | Other | Cervical brush, Microm Microtech, FLOQSwab, Copan Diagnostics, Rhino-Pro Curette, Arlington Scientific |
| ELISAELISA to measure antibody responses in mucosal fluids and blood | Diagnostic test | Cervical brush, Microm Microtech, FLOQSwab, Copan Diagnostics, Rhino-Pro Curette, Arlington Scientific |
| Neutralization testNeutralization test to measure neutralizing antibody responses in mucosal fluids and blood to measure neutralizing antibody responses in mucosal fluids and blood | Diagnostic test | Cervical brush, Microm Microtech, FLOQSwab, Copan Diagnostics, Rhino-Pro Curette, Arlington Scientific |
| ELISPotELISPot to measure cellular responses in blood | Diagnostic test | Cervical brush, Microm Microtech, FLOQSwab, Copan Diagnostics, Rhino-Pro Curette, Arlington Scientific |
| TranscriptomicsTranscriptomics to quantify the gene expression of immunological markers in blood | Diagnostic test | Cervical brush, Microm Microtech, FLOQSwab, Copan Diagnostics, Rhino-Pro Curette, Arlington Scientific |
Primary outcome
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
3 secondary outcomes
Frequencies of resident memory T and B lymphocytes
Time frame: 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
Visual analog scale for pain
Time frame: At inclusion, one month, two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ELISABETH BOTELHO-NEVERS, MD-PhD principal investigator
CHU DE SAINT-ETIENNE
STEPHANE PAUL, MD-PhD study director
CHU de Saint-Etienne
STEPHANIE LONGUET, PhD study chair
Université de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal tissue-resident memory T and B cells, Nasal fluid sampling and Saliva sampling in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab (time frame: At inclusion, one month, two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.