Skip to main content
Clinical Trials/NCT06469359
NCT06469359
Completed
Not Applicable

Development of a Methodology to Analyze Nasal Tissue-resident Memory Immune Cells and Peripheral Memory Cells Able to Migrate to Airway Tissues (MUCOVAC)

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country30 target enrollmentJuly 22, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Volunteers
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
30
Locations
1
Primary Endpoint
Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab
Status
Completed
Last Updated
last year

Overview

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. .

Registry
clinicaltrials.gov
Start Date
July 22, 2024
End Date
November 11, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Visual analog scale for pain(At inclusion, one month, two months)
  • Frequencies of resident memory T and B lymphocytes(At inclusion, one month, two months)
  • Expression levels of respiratory mucosal migration markers on peripheral memory lymphocytes(At inclusion, one month, two months)

Study Sites (1)

Loading locations...

Similar Trials