NCT06469359

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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. .

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-22
• Primary completion: 2024-11-11
• Completion: 2024-11-11
• First posted: 2024-06-21
• Last updated: 2024-12-18

Locations

1 site across 1 country: France