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

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

Interventions

DEVICE

Nasal tissue-resident memory T and B cells

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

DEVICE

Nasal fluid sampling

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

DEVICE

Saliva sampling

Saliva is collected using Oracol (Malvern Medical Developments)

OTHER

Blood sampling

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

DIAGNOSTIC_TEST

ELISA

ELISA to measure antibody responses in mucosal fluids and blood

DIAGNOSTIC_TEST

Neutralization test

Neutralization test to measure neutralizing antibody responses in mucosal fluids and blood to measure neutralizing antibody responses in mucosal fluids and blood

DIAGNOSTIC_TEST

ELISPot

ELISPot to measure cellular responses in blood

DIAGNOSTIC_TEST

Transcriptomics

Transcriptomics to quantify the gene expression of immunological markers in blood

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company

  collaborator INDUSTRY

• Centre Hospitalier Universitaire de Saint Etienne

  lead OTHER

Principal Investigators

• ELISABETH BOTELHO-NEVERS, MD-PhD · CHU DE SAINT-ETIENNE

• STEPHANE PAUL, MD-PhD · CHU de Saint-Etienne

• STEPHANIE LONGUET, PhD · Université de Saint-Etienne

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-22

Primary Completion

2024-11-11

Completion

2024-11-11

Countries

• France

Study Locations