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

NCT06469359 | Completed

• 2 other identifiers: 23CH2942024-A00255-42
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Nasal immune cells; sampling device; airway immunity; memory immune responses; T cells; B cells

Outcome Measures

Primary Outcomes (1)

• 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

  At inclusion, one month, two months

Secondary Outcomes (3)

• 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

• Visual analog scale for pain

  At inclusion, one month, two months

Study Arms (3)

FLOQSwab, Copan Diagnostics

EXPERIMENTAL

Nasal cells are collected in both nostrils using one FLOQSwab per nostril

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

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

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

Interventions

Nasal tissue-resident memory T and B cells DEVICE

Nasal tissue-resident memory T and B cells are quantified using flow cytometry.

Cervical brush, Microm Microtech; FLOQSwab, Copan Diagnostics; Rhino-Pro Curette, Arlington Scientific

Nasal fluid sampling DEVICE

Nasal fluid is collected using strip (Hunt Development) in both nostrils

Cervical brush, Microm Microtech; FLOQSwab, Copan Diagnostics; Rhino-Pro Curette, Arlington Scientific

Saliva sampling DEVICE

Saliva is collected using Oracol (Malvern Medical Developments)

Cervical brush, Microm Microtech; FLOQSwab, Copan Diagnostics; Rhino-Pro Curette, Arlington Scientific

Blood sampling OTHER

Isolation of peripheral blood mononuclear cells (PBMC) and serum from blood

Cervical brush, Microm Microtech; FLOQSwab, Copan Diagnostics; Rhino-Pro Curette, Arlington Scientific

ELISA DIAGNOSTIC_TEST

ELISA to measure antibody responses in mucosal fluids and blood

Cervical brush, Microm Microtech; FLOQSwab, Copan Diagnostics; Rhino-Pro Curette, Arlington Scientific

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

Cervical brush, Microm Microtech; FLOQSwab, Copan Diagnostics; Rhino-Pro Curette, Arlington Scientific

ELISPot DIAGNOSTIC_TEST

ELISPot to measure cellular responses in blood

Cervical brush, Microm Microtech; FLOQSwab, Copan Diagnostics; Rhino-Pro Curette, Arlington Scientific

Transcriptomics DIAGNOSTIC_TEST

Transcriptomics to quantify the gene expression of immunological markers in blood

Cervical brush, Microm Microtech; FLOQSwab, Copan Diagnostics; Rhino-Pro Curette, Arlington Scientific

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Affiliated to the Social Security System
• Signed informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Sanofi Pasteur, a Sanofi Company: collaborator

Study Sites (1)

Centre Hospitalier Universitaire

Saint-Etienne, 42055, France

Location

MeSH Terms

Interventions

Blood Specimen Collection; Neutralization Tests; Enzyme-Linked Immunospot Assay

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Serologic Tests; Immunologic Tests; Immunologic Techniques; Cytological Techniques; Enzyme-Linked Immunosorbent Assay; Immunoenzyme Techniques; Immunoassay; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective study in healthy volunteers. Randomized, single-blind, cross-over trial

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 21, 2024
• Study Start: July 22, 2024
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)