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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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