Analyzes of Nasal Tissue-resident Memory Immune Cells and Peripheral Memory Cells Able to Migrate to Airway Tissues (MUCOVAC)
- Conditions
- Healthy Volunteers
- Interventions
- Device: Nasal tissue-resident memory T and B cellsDevice: Nasal fluid samplingDevice: Saliva samplingOther: Blood samplingDiagnostic Test: ELISADiagnostic Test: Neutralization testDiagnostic Test: ELISPotDiagnostic Test: Transcriptomics
- Registration Number
- NCT06469359
- Brief 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. 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. .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Affiliated to the Social Security System
- Signed informed consent form
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description FLOQSwab, Copan Diagnostics Saliva sampling Nasal cells are collected in both nostrils using one FLOQSwab per nostril FLOQSwab, Copan Diagnostics ELISA Nasal cells are collected in both nostrils using one FLOQSwab per nostril FLOQSwab, Copan Diagnostics Neutralization test Nasal cells are collected in both nostrils using one FLOQSwab per nostril Rhino-Pro Curette, Arlington Scientific Nasal fluid sampling Nasal cells are collected in both nostrils using one curette per nostril FLOQSwab, Copan Diagnostics Nasal tissue-resident memory T and B cells Nasal cells are collected in both nostrils using one FLOQSwab per nostril FLOQSwab, Copan Diagnostics Nasal fluid sampling Nasal cells are collected in both nostrils using one FLOQSwab per nostril FLOQSwab, Copan Diagnostics Blood sampling Nasal cells are collected in both nostrils using one FLOQSwab per nostril FLOQSwab, Copan Diagnostics ELISPot Nasal cells are collected in both nostrils using one FLOQSwab per nostril FLOQSwab, Copan Diagnostics Transcriptomics Nasal cells are collected in both nostrils using one FLOQSwab per nostril Rhino-Pro Curette, Arlington Scientific ELISA Nasal cells are collected in both nostrils using one curette per nostril Rhino-Pro Curette, Arlington Scientific Saliva sampling Nasal cells are collected in both nostrils using one curette per nostril Cervical brush, Microm Microtech Nasal tissue-resident memory T and B cells Nasal cells are collected in both nostrils using one brush per nostril Cervical brush, Microm Microtech Saliva sampling Nasal cells are collected in both nostrils using one brush per nostril Cervical brush, Microm Microtech Blood sampling Nasal cells are collected in both nostrils using one brush per nostril Cervical brush, Microm Microtech ELISPot Nasal cells are collected in both nostrils using one brush per nostril Rhino-Pro Curette, Arlington Scientific Nasal tissue-resident memory T and B cells Nasal cells are collected in both nostrils using one curette per nostril Rhino-Pro Curette, Arlington Scientific Transcriptomics Nasal cells are collected in both nostrils using one curette per nostril Rhino-Pro Curette, Arlington Scientific Blood sampling Nasal cells are collected in both nostrils using one curette per nostril Rhino-Pro Curette, Arlington Scientific ELISPot Nasal cells are collected in both nostrils using one curette per nostril Cervical brush, Microm Microtech Transcriptomics Nasal cells are collected in both nostrils using one brush per nostril Rhino-Pro Curette, Arlington Scientific Neutralization test Nasal cells are collected in both nostrils using one curette per nostril Cervical brush, Microm Microtech Nasal fluid sampling Nasal cells are collected in both nostrils using one brush per nostril Cervical brush, Microm Microtech Neutralization test Nasal cells are collected in both nostrils using one brush per nostril Cervical brush, Microm Microtech ELISA Nasal cells are collected in both nostrils using one brush per nostril
- Primary Outcome Measures
Name Time Method Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab At inclusion, one month, two months This outcome is measured by the three devices :
* FLOQSwab
* Rhino-Pro Curette
* Cervical brush
- Secondary Outcome Measures
Name Time Method Visual analog scale for pain 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 brushFrequencies of resident memory T and B lymphocytes 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 brushExpression levels of respiratory mucosal migration markers on peripheral memory lymphocytes At inclusion, one month, two months This outcome is measured by the three devices :
* FLOQSwab
* Rhino-Pro Curette
* Cervical brush
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire
🇫🇷Saint-Étienne, France