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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00255-42 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
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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.
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. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLOQSwab, Copan Diagnostics | Experimental | Nasal cells are collected in both nostrils using one FLOQSwab per nostril |
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| Rhino-Pro Curette, Arlington Scientific | Experimental | Nasal cells are collected in both nostrils using one curette per nostril |
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| Cervical brush, Microm Microtech | Experimental | Nasal cells are collected in both nostrils using one brush per nostril |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal tissue-resident memory T and B cells | Device | Nasal tissue-resident memory T and B cells are quantified using flow cytometry. |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab | This outcome is measured by the three devices :
| At inclusion, one month, two months |
| 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 :
| At inclusion, one month, two months |
| Expression levels of respiratory mucosal migration markers on peripheral memory lymphocytes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ELISABETH BOTELHO-NEVERS, MD-PhD | CHU DE SAINT-ETIENNE | Principal Investigator |
| STEPHANE PAUL, MD-PhD | CHU de Saint-Etienne | Study Director |
| STEPHANIE LONGUET, PhD | Université de Saint-Etienne | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire | Saint-Etienne | 42055 | France |
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Prospective study in healthy volunteers. Randomized, single-blind, cross-over trial
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| Nasal fluid sampling | Device | Nasal fluid is collected using strip (Hunt Development) in both nostrils |
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| Saliva sampling | Device | Saliva is collected using Oracol (Malvern Medical Developments) |
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| Blood sampling | Other | Isolation of peripheral blood mononuclear cells (PBMC) and serum from blood |
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| ELISA | Diagnostic Test | ELISA to measure antibody responses in mucosal fluids and blood |
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| Neutralization test | Diagnostic Test | Neutralization test to measure neutralizing antibody responses in mucosal fluids and blood to measure neutralizing antibody responses in mucosal fluids and blood |
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| ELISPot | Diagnostic Test | ELISPot to measure cellular responses in blood |
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| Transcriptomics | Diagnostic Test | Transcriptomics to quantify the gene expression of immunological markers in blood |
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This outcome is measured by the three devices :
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| 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 :
| At inclusion, one month, two months |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D009500 | Neutralization Tests |
| D058501 | Enzyme-Linked Immunospot Assay |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D012698 | Serologic Tests |
| D007159 | Immunologic Tests |
| D007158 | Immunologic Techniques |
| D003584 | Cytological Techniques |
| D004797 | Enzyme-Linked Immunosorbent Assay |
| D007124 | Immunoenzyme Techniques |
| D007118 | Immunoassay |
| D007163 | Immunosorbent Techniques |
| D007150 | Immunohistochemistry |
| D015336 | Molecular Probe Techniques |
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