Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-31 @ 6:55 PM
Study NCT ID:
NCT05951920
Status:
UNKNOWN
Last Update Posted:
2023-07-21
First Post:
2023-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lymph Node Aspiration to Decipher the Immune Response of Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2023-07-17', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Spike and/or RBD-specific germinal center B cell response', 'timeFrame': 'Day 1', 'description': 'As part of an ancillary study of COVIBOOST2 to analyse the percentage of Hu-1, Delta or Omicron Spike and RBD-specific germinal center B cells in draining lymph nodes 3-8 weeks after the Beta-variant recombinant protein booster vaccine (VidPrevtyn®Beta, Sanofi) or the bivalent mRNA vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer), in adults previously vaccinated with at least 3 doses of COVID-19 mRNA vaccine, the last dose received at least 6 months prior the inclusion in the study.'}, {'measure': 'The Spike and/or RBD-specific germinal center B cell repertoire', 'timeFrame': 'Day 1', 'description': 'As part of an ancillary study of COVIBOOST2 to analyse the percentage of Hu-1, Delta or Omicron Spike and RBD-specific germinal center B cells in draining lymph nodes 3-8 weeks after the Beta-variant recombinant protein booster vaccine (VidPrevtyn®Beta, Sanofi) or the bivalent mRNA vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer), in adults previously vaccinated with at least 3 doses of COVID-19 mRNA vaccine, the last dose received at least 6 months prior the inclusion in the study.'}], 'secondaryOutcomes': [{'measure': 'The repertoire of the cellular germinal center B immune response in the two arms.', 'timeFrame': 'Day 1', 'description': 'To determine the number of somatic hypermutations in the immunoglobulin heavy chain of each single Hu-1, Delta or Omicron Spike/RBD-specific germinal center cells. To determine the number of clonal relationships between Spike/RBD- specific germinal center B cells in draining lymph nodes with memory B cells in peripheral blood.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID 19', 'mRNA vaccines', 'Immunology', 'Sub-unit vaccine', 'Booster', 'lymph nod', 'memory B cell'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'In order to investigate whether a germinal center response occurs following vaccine boost and to characterize it based on the type of vaccine received, we aim to analyze Spike and/or RBD-specific germinal center B cells within the draining lymph nodes.\n\nTo achieve this, we will perform lymph node fine needle aspiration of the draining lymph node in 6 subjects in each study arm, 3 to 6 weeks after the booster vaccine injection.', 'detailedDescription': 'Lymph nodes are secondary lymphoid organs essential for the establishment of the germinal center reaction, allowing the generation of long-lived B cell memory and high-affinity antibodies. In order to investigate whether a germinal center response occurs following vaccine boost and to characterize it based on the type of vaccine received, we aim to analyze Spike and/or RBD-specific germinal center B cells within the draining lymph nodes. Accessing germinal center through fine needle aspirations under ultrasound guidance has recently emerged as an innovative strategy in the United States to investigate vaccine response. This procedure under local anesthesia is well-tolerated, and no major side effects have been reported in a hundred patients who underwent fine needle aspiration. The technical details for performing this examination are now well-described.\n\nOur previous work has highlighted the importance of repertoire diversity in responding to new variants of SARS-CoV-2. We thus aim to investigate whether a booster dose with mRNA or protein-based vaccine mobilizes memory B cells or naive cells, thereby contributing to a greater diversity of the Memory B cell comportment. To preserve the diversity of the memory B cell pool is absolutely essential for our immune system to adapt against variants.\n\nTo achieve this, we will perform lymph node fine needle aspiration of the draining lymph node in 6 subjects in each study arm, 3 to 6 weeks after the booster vaccine injection. Indeed, it has been shown that the response of germinal centers in response to a booster vaccination was detectable at 2- and 8-weeks post-injection vaccination.\n\nThis outpatient procedure will be performed by a radiologist under ultrasound guidance, aiming to collect 4 fine needle aspirations from 4 axillary draining lymph nodes under local anesthesia. Concurrently, a 35 mL blood sample will be collected from the subject to correlate the response in secondary lymphoid organs with the circulating response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 years and over included in COVIBOOST 2\n\nExclusion Criteria:\n\n* Hypersensitivity to lidocaine, to anaesthetics of the amide type or to any of the excipients\n* Patient with recurrent porphyrias'}, 'identificationModule': {'nctId': 'NCT05951920', 'acronym': 'LymphoBOOST', 'briefTitle': 'Lymph Node Aspiration to Decipher the Immune Response of Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine.', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Lymph Node Aspiration to Decipher the Immune Response of Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine. Ancillary of COVIBOOST 2', 'orgStudyIdInfo': {'id': 'APHP230684'}, 'secondaryIdInfos': [{'id': '2023-A01335-40', 'type': 'OTHER', 'domain': 'IDRCB ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lymph node aspiration / Blood sampling', 'interventionNames': ['Procedure: Lymph node aspiration / Blood sampling']}], 'interventions': [{'name': 'Lymph node aspiration / Blood sampling', 'type': 'PROCEDURE', 'description': 'Lymph node aspiration / Blood sampling', 'armGroupLabels': ['Lymph node aspiration / Blood sampling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75679', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Odile LAUNAY, Pr', 'role': 'CONTACT', 'email': 'odile.launay@aphp.fr', 'phone': '+ 33 1 58 41 28 58'}, {'name': 'Marie LACHATRE, PH', 'role': 'CONTACT', 'email': 'marie.lachatre@aphp.fr', 'phone': '+ 33 1 58 41 28 58'}], 'facility': 'GH Broca-Cochin-Hôtel-Dieu CIC 1417 Cochin-Pasteur', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Odile LAUNAY, Pr', 'role': 'CONTACT', 'email': 'odile.launay@aphp.fr', 'phone': '+ 33 1 58 41 27 41'}, {'name': 'Marie LACHATRE', 'role': 'CONTACT', 'email': 'marie.lachatre@aphp.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The IPD will not be share. The 2 vaccines used in this study are marketed vaccine and used in routine care'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}