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

Healthy Volunteers Clinical Trial

— MUCOVAC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06469359
• Other study ID #: 23CH294
• Secondary ID: 2024-A00255-42
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: ELISABETH BOTELHO-NEVERS, MD-PhD
• Phone: (0)477829234
• Email: Elisabeth.Botelho-Nevers[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• Nasal tissue-resident memory T and B cells
Nasal tissue-resident memory T and B cells are quantified using flow cytometry.
• Nasal fluid sampling
Nasal fluid is collected using strip (Hunt Development) in both nostrils
• 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
• Neutralization test
Neutralization test to measure neutralizing antibody responses in mucosal fluids and blood to measure neutralizing antibody responses in mucosal fluids and blood
• ELISPot
ELISPot to measure cellular responses in blood
• Transcriptomics
Transcriptomics to quantify the gene expression of immunological markers in blood

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequencies of resident memory T and B lymphocytes	Frequencies of resident memory T and B lymphocytes are measured by the three devices : FLOQSwab; Rhino-Pro Curette; Cervical brush	At inclusion, one month, two months
Secondary	Expression levels of respiratory mucosal migration markers on peripheral memory lymphocytes	This outcome is measured by the three devices : FLOQSwab; Rhino-Pro Curette; Cervical brush	At inclusion, one month, two months
Secondary	Visual analog scale for pain	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	At inclusion, one month, two months