Healthy Volunteers
Conditions
Keywords
Nasal immune cells, sampling device, airway immunity, memory immune responses, T cells, B cells
Brief 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. .
Interventions
DEVICENasal tissue-resident memory T and B cells
Nasal tissue-resident memory T and B cells are quantified using flow cytometry.
DEVICENasal fluid sampling
Nasal fluid is collected using strip (Hunt Development) in both nostrils
DEVICESaliva sampling
Saliva is collected using Oracol (Malvern Medical Developments)
OTHERBlood sampling
Isolation of peripheral blood mononuclear cells (PBMC) and serum from blood
DIAGNOSTIC_TESTELISA
ELISA to measure antibody responses in mucosal fluids and blood
DIAGNOSTIC_TESTNeutralization test
Neutralization test to measure neutralizing antibody responses in mucosal fluids and blood to measure neutralizing antibody responses in mucosal fluids and blood
DIAGNOSTIC_TESTELISPot
ELISPot to measure cellular responses in blood
DIAGNOSTIC_TESTTranscriptomics
Transcriptomics to quantify the gene expression of immunological markers in blood
Sponsors
Sanofi Pasteur, a Sanofi Company
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Intervention model description
Prospective study in healthy volunteers. Randomized, single-blind, cross-over trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab | At inclusion, one month, two months | This outcome is measured by the three devices : * FLOQSwab * Rhino-Pro Curette * Cervical brush |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequencies of resident memory T and B lymphocytes | 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 |
| Expression levels of respiratory mucosal migration markers on peripheral memory lymphocytes | At inclusion, one month, two months | This outcome is measured by the three devices : * FLOQSwab * Rhino-Pro Curette * Cervical brush |
| Visual analog scale for pain | 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 |
Countries
France
Outcome results
None listed