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

Not Applicable

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT06469359
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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. .

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-21
• Study Start: 2024-07-22
• Primary Completion: 2024-11-11
• Study Completion: 2024-11-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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 brush
Frequencies 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 brush
Expression 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