Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-01-01 @ 9:04 PM
Study NCT ID:
NCT06469359
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2024-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analyzes of Nasal Tissue-resident Memory Immune Cells and Peripheral Memory Cells Able to Migrate to Airway Tissues (MUCOVAC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D009500', 'term': 'Neutralization Tests'}, {'id': 'D058501', 'term': 'Enzyme-Linked Immunospot Assay'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012698', 'term': 'Serologic Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D004797', 'term': 'Enzyme-Linked Immunosorbent Assay'}, {'id': 'D007124', 'term': 'Immunoenzyme Techniques'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007163', 'term': 'Immunosorbent Techniques'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective study in healthy volunteers. Randomized, single-blind, cross-over trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of resident memory lymphocytes in the nasal mucosa measured by FLOQSwab', 'timeFrame': 'At inclusion, one month, two months', 'description': 'This outcome is measured by the three devices :\n\n* FLOQSwab\n* Rhino-Pro Curette\n* Cervical brush'}], 'secondaryOutcomes': [{'measure': 'Frequencies of resident memory T and B lymphocytes', 'timeFrame': 'At inclusion, one month, two months', 'description': 'Frequencies of resident memory T and B lymphocytes are measured by the three devices :\n\n* FLOQSwab\n* Rhino-Pro Curette\n* Cervical brush'}, {'measure': 'Expression levels of respiratory mucosal migration markers on peripheral memory lymphocytes', 'timeFrame': 'At inclusion, one month, two months', 'description': 'This outcome is measured by the three devices :\n\n* FLOQSwab\n* Rhino-Pro Curette\n* Cervical brush'}, {'measure': 'Visual analog scale for pain', 'timeFrame': 'At inclusion, one month, two months', 'description': 'Scale from 0 to 10 (0 = no pain, 10 = intolerable pain)\n\nThis outcome is measured by the three devices :\n\n* FLOQSwab\n* Rhino-Pro Curette\n* Cervical brush'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasal immune cells', 'sampling device', 'airway immunity', 'memory immune responses', 'T cells', 'B cells'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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. .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Affiliated to the Social Security System\n* Signed informed consent form\n\nExclusion Criteria:\n\n* History of recurrent nosebleeds or systemic hemorrhages\n* Previous injury or surgery which modified nasal cavity (e.g. deviated nasal septum)\n* Individuals receiving anticoagulant therapy\n* Individuals who experienced a severe respiratory infection leading to hospitalization in the last 6 months\n* Individuals who received an antibiotic therapy for respiratory infection or any other infection in the last 6 months\n* 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\n* Unstable chronic pathology\n* People deprived of liberty or hospitalized without any consent\n* People under guardianship (authorship or curators)\n* Individuals who received a vaccine (any vaccine) in the last 30 days\n* Pregnant or breast-feeding people\n* Individuals experiencing respiratory infection symptoms. Inclusion will be postponed up to 7 days after the symptom resolution"}, 'identificationModule': {'nctId': 'NCT06469359', 'acronym': 'MUCOVAC', 'briefTitle': 'Analyzes of Nasal Tissue-resident Memory Immune Cells and Peripheral Memory Cells Able to Migrate to Airway Tissues (MUCOVAC)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Development of a Methodology to Analyze Nasal Tissue-resident Memory Immune Cells and Peripheral Memory Cells Able to Migrate to Airway Tissues (MUCOVAC)', 'orgStudyIdInfo': {'id': '23CH294'}, 'secondaryIdInfos': [{'id': '2024-A00255-42', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FLOQSwab, Copan Diagnostics', 'description': 'Nasal cells are collected in both nostrils using one FLOQSwab per nostril', 'interventionNames': ['Device: Nasal tissue-resident memory T and B cells', 'Device: Nasal fluid sampling', 'Device: Saliva sampling', 'Other: Blood sampling', 'Diagnostic Test: ELISA', 'Diagnostic Test: Neutralization test', 'Diagnostic Test: ELISPot', 'Diagnostic Test: Transcriptomics']}, {'type': 'EXPERIMENTAL', 'label': 'Rhino-Pro Curette, Arlington Scientific', 'description': 'Nasal cells are collected in both nostrils using one curette per nostril', 'interventionNames': ['Device: Nasal tissue-resident memory T and B cells', 'Device: Nasal fluid sampling', 'Device: Saliva sampling', 'Other: Blood sampling', 'Diagnostic Test: ELISA', 'Diagnostic Test: Neutralization test', 'Diagnostic Test: ELISPot', 'Diagnostic Test: Transcriptomics']}, {'type': 'EXPERIMENTAL', 'label': 'Cervical brush, Microm Microtech', 'description': 'Nasal cells are collected in both nostrils using one brush per nostril', 'interventionNames': ['Device: Nasal tissue-resident memory T and B cells', 'Device: Nasal fluid sampling', 'Device: Saliva sampling', 'Other: Blood sampling', 'Diagnostic Test: ELISA', 'Diagnostic Test: Neutralization test', 'Diagnostic Test: ELISPot', 'Diagnostic Test: Transcriptomics']}], 'interventions': [{'name': 'Nasal tissue-resident memory T and B cells', 'type': 'DEVICE', 'description': 'Nasal tissue-resident memory T and B cells are quantified using flow cytometry.', 'armGroupLabels': ['Cervical brush, Microm Microtech', 'FLOQSwab, Copan Diagnostics', 'Rhino-Pro Curette, Arlington Scientific']}, {'name': 'Nasal fluid sampling', 'type': 'DEVICE', 'description': 'Nasal fluid is collected using strip (Hunt Development) in both nostrils', 'armGroupLabels': ['Cervical brush, Microm Microtech', 'FLOQSwab, Copan Diagnostics', 'Rhino-Pro Curette, Arlington Scientific']}, {'name': 'Saliva sampling', 'type': 'DEVICE', 'description': 'Saliva is collected using Oracol (Malvern Medical Developments)', 'armGroupLabels': ['Cervical brush, Microm Microtech', 'FLOQSwab, Copan Diagnostics', 'Rhino-Pro Curette, Arlington Scientific']}, {'name': 'Blood sampling', 'type': 'OTHER', 'description': 'Isolation of peripheral blood mononuclear cells (PBMC) and serum from blood', 'armGroupLabels': ['Cervical brush, Microm Microtech', 'FLOQSwab, Copan Diagnostics', 'Rhino-Pro Curette, Arlington Scientific']}, {'name': 'ELISA', 'type': 'DIAGNOSTIC_TEST', 'description': 'ELISA to measure antibody responses in mucosal fluids and blood', 'armGroupLabels': ['Cervical brush, Microm Microtech', 'FLOQSwab, Copan Diagnostics', 'Rhino-Pro Curette, Arlington Scientific']}, {'name': 'Neutralization test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Neutralization test to measure neutralizing antibody responses in mucosal fluids and blood to measure neutralizing antibody responses in mucosal fluids and blood', 'armGroupLabels': ['Cervical brush, Microm Microtech', 'FLOQSwab, Copan Diagnostics', 'Rhino-Pro Curette, Arlington Scientific']}, {'name': 'ELISPot', 'type': 'DIAGNOSTIC_TEST', 'description': 'ELISPot to measure cellular responses in blood', 'armGroupLabels': ['Cervical brush, Microm Microtech', 'FLOQSwab, Copan Diagnostics', 'Rhino-Pro Curette, Arlington Scientific']}, {'name': 'Transcriptomics', 'type': 'DIAGNOSTIC_TEST', 'description': 'Transcriptomics to quantify the gene expression of immunological markers in blood', 'armGroupLabels': ['Cervical brush, Microm Microtech', 'FLOQSwab, Copan Diagnostics', 'Rhino-Pro Curette, Arlington Scientific']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'ELISABETH BOTELHO-NEVERS, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU DE SAINT-ETIENNE'}, {'name': 'STEPHANE PAUL, MD-PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU de Saint-Etienne'}, {'name': 'STEPHANIE LONGUET, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Université de Saint-Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}