Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-02 @ 4:04 AM
Study NCT ID:
NCT05869968
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2023-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and a self-collected nasal swab will be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2023-05-19', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mRNA transcript levels for genes expressed according to white blood cell type after flu vaccination', 'timeFrame': '0-28 days after flu vaccination', 'description': 'Serum samples will be used to determine if gene expression levels made by specific types of white blood cells are different between participant groups and within the SCI group by injury level and severity.'}, {'measure': 'Anti-flu antibody titers in response to vaccination', 'timeFrame': '0-28 days after flu vaccination', 'description': 'Serum samples will be used to determine antibody titers for anti-flu antibodies at baseline and after vaccination. These samples will be obtained to determine if vaccine responses are different between participant groups and within the SCI group by injury level and severity'}], 'secondaryOutcomes': [{'measure': 'mRNA transcript levels for genes expressed according to white blood cell type after COVID-19 vaccination', 'timeFrame': '0-28 days after COVID-19 vaccination', 'description': 'Serum samples will be used to determine if gene expression levels made by specific types of white blood cells are different between participant groups and within the SCI group by injury level and severity.'}, {'measure': 'Anti-COVID-19 antibody titers in response to vaccination', 'timeFrame': '0-28 days after COVID-19 vaccination', 'description': 'Serum samples will be used to determine antibody titers for anti-COVID-19 antibodies at baseline and after vaccination. These samples will be obtained to determine if vaccine responses are different between participant groups and within the SCI group by injury level and severity'}, {'measure': 'Systemic inflammatory cytokine levels in response to vaccination', 'timeFrame': '0-28 days after vaccination', 'description': 'Serum samples will be used to determine systemic inflammatory cytokine levels at baseline and after flu or COVID-19 vaccination. These samples will be obtained to determine if cytokine levels are different between participant groups and within the SCI group by injury level and severity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Spinal Cord Injury', 'Flu Vaccination', 'COVID-19 Vaccination', 'Immune Responsiveness'], 'conditions': ['Spinal Cord Injuries', 'Traumatic Spinal Cord Injury', 'Healthy Controls', 'Flu Vaccine', 'COVID-19 Vaccine']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational research study is to better understand immune responses to vaccines against viruses (influenza or SARS-CoV2). The goal is to determine any differences in immune responses to vaccines in uninjured people and in people living with spinal cord injuries, who are typically at increased risk of infections.', 'detailedDescription': "The purpose of this research study is to measure a person's immune response to a vaccine by measuring types of circulating white blood cells (WBC) and the substances they produce in blood, including antibodies, proteins, and ribonucleic acids (the body's genetic blueprint for making proteins).\n\nThe research will study two populations: uninjured people and people living with spinal cord injury (SCI), who are often at increased risk of infections. We will measure and observe over time any differences in immune responses to vaccines between those groups or among people with SCI according to their injury severity or level.\n\nThe overall goal of this study is to increase knowledge of immune responses to vaccination against influenza virus that causes the flu, and to the SARS-CoV-2 virus that causes COVID-19. There is currently a lack of information about what influences individual responses to vaccines and why people with SCI are at typically at increased risk of infection. Results from this study may teach us how to improve vaccination strategies and other ways to fight infections in uninjured people and in people with SCI"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be adults (ages 18-89 years old) with SCI or who are uninjured controls who are electing to receiving flu or COVID-19 vaccines to promote their health.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nSCI Participant Inclusion Criteria: To be eligible for prospective enrollment, participants are required to meet the following inclusion criteria:\n\n* 18-89 years old with traumatic SCI\n* initial traumatic SCI \\>/=1 year from enrollment (DOD funded study)\n* initial traumatic SCI \\<1 year from enrollment (non-DOD funded pilot study)\n* American Spinal Injury Association (ASIA) classification grade A-D\n* Neurological Injury Level C1-T10\n* Demonstrate capacity to provide informed consent using the "teach back" method to verify understanding and appreciation of study objectives and procedures.\n\nExclusion Criteria\n\nTo be eligible for prospective enrollment, SCI participants are required to not meet the following exclusion criteria:\n\n* Stage III-IV pressure ulcers\n* Cancer, chemotherapy, neutropenia\n* Pregnancy or lactation\n* No known SCI\n* Autoimmune disease\n* Pre-existing neurological disease\n* History of dementia\n* Any other condition that would compromise their ability to provide informed consent\n* Any other condition that a study physician feels would preclude participation or be contraindicated\n\nUninjured Control Group:\n\nInclusion Criteria\n\nUninjured Control Participant Inclusion Criteria: To be eligible for prospective enrollment, participants are required to meet the following inclusion criteria:\n\n* 18-89 years old without traumatic SCI\n* Demonstrate capacity to provide informed consent using the "teach back" method to verify understanding and appreciation of study objectives and procedures.\n\nExclusion Criteria\n\nTo be eligible for prospective enrollment, uninjured control participants are required to not meet the following exclusion criteria:\n\n* Cancer, chemotherapy, neutropenia\n* Pregnancy or lactation\n* Autoimmune disease\n* Pre-existing neurological disease\n* History of dementia\n* Any other condition that would compromise their ability to provide informed consent\n* Any other condition that a study physician feels would preclude participation or be contraindicated'}, 'identificationModule': {'nctId': 'NCT05869968', 'acronym': 'SCIVAX', 'briefTitle': 'SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Biomarkers of Immune Dysfunction and Vaccine Responsiveness in People With Chronic Traumatic Spinal Cord Injury', 'orgStudyIdInfo': {'id': '22-0787-FIMR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with Chronic Spinal Cord Injury who receive either Flu or COVID-19 vaccine', 'description': '18-89 years old with traumatic SCI, AIS grade A-D, Neurological injury level of C1-T10 who are choosing to receive a vaccine against the flu or COVID-19 and demonstrate capacity to provide informed consent.'}, {'label': 'Uninjured Controls who receive the Flu vaccine or COVID-19 vaccine', 'description': '18-89 years old without traumatic Spinal Cord Injury (SCI) who are choosing to receive a vaccine against either the Flu or COVID-19 and demonstrate the capacity to provide informed consent.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ona Bloom, PhD', 'role': 'CONTACT', 'email': 'obloom@northwell.edu', 'phone': '516-562-3839'}, {'name': 'Welmi Pello, MPH', 'role': 'CONTACT', 'email': 'wpello@northwell.edu', 'phone': '516-562-1331'}], 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'centralContacts': [{'name': 'Welmince Pello, MPH', 'role': 'CONTACT', 'email': 'wpello@northwell.edu', 'phone': '516-562-1331'}, {'name': 'Joy Cambe, MD, MPH', 'role': 'CONTACT', 'email': 'jcambe@northwell.edu', 'phone': '516-562-1331'}], 'overallOfficials': [{'name': 'Ona Bloom, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Feinstein Institute for Medical Research; Northwell Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'New York State Department of Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ona Bloom', 'investigatorAffiliation': 'Northwell Health'}}}}