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Completed

NCT Number: NCT06469359

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire

Saint-Etienne, 42055, France

About this study

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. .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal tissue-resident memory T and B cells

Device

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

Nasal fluid sampling

Device

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

Saliva sampling

Device

Saliva is collected using Oracol (Malvern Medical Developments)

Blood sampling

Other

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

ELISA

Diagnostic Test

ELISA to measure antibody responses in mucosal fluids and blood

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

ELISPOT

Diagnostic Test

ELISPot to measure cellular responses in blood

Transcriptomics

Diagnostic Test

Transcriptomics to quantify the gene expression of immunological markers in blood

Primary outcomes

  1. 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

  1. Frequencies of resident memory T and B lymphocytes

    Time frame: 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

  2. Expression levels of respiratory mucosal migration markers on peripheral memory lymphocytes

    Time frame: At inclusion, one month, two months

    This outcome is measured by the three devices :

    • FLOQSwab
    • Rhino-Pro Curette
    • Cervical brush

  3. Visual analog scale for pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Sanofi Pasteur, a Sanofi Company

Registry information

Official study title

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

Acronym: MUCOVAC

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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