Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-06-13 @ 8:24 PM
Study NCT ID:
NCT05067959
Status:
UNKNOWN
Last Update Posted:
2021-10-05
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases
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': 'D000086663', 'term': 'COVID-19 Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'complete blood count, CRP, Anti-TNF level and trough from relevant patients, COVID-19 serology including neutralizing antibodies, cytokine levels, lymphocyte subpopulation \\[CD4 CD8 B CD20/19, NKT\\], T cell proliferation, immunoglobulin levels.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-03', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-10-03', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vaccine efficacy in IBD population', 'timeFrame': '4 weeks post second COVID-19 vaccine.', 'description': '• Efficacy of the vaccination for IBD patients compared to the normal population measured as proportion of patients achieving positive serology'}], 'secondaryOutcomes': [{'measure': 'Disease related variant affect immunological response', 'timeFrame': '12 months', 'description': 'Measuring how the IBD disease activity (remission or flare) affect the response to the vaccine'}, {'measure': 'Therapy related variants affect immunological response', 'timeFrame': '12 months', 'description': 'Measuring how specific IBD therapies and doses, during induction or maintenance, interval between vaccination and anti TNF infusion/injection affect the response to the vaccine'}, {'measure': 'Immunologic assessments affect response to vaccine', 'timeFrame': '12 months', 'description': 'Measuring how immunoglobulin levels, lymphocyte subpopulations and HLA phenotype affect the response to the vaccine'}, {'measure': 'Adverse Events to covid-19 vaccine', 'timeFrame': '12 months', 'description': 'Following Adverse reactions to vaccines'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IBD', 'Covid19']}, 'descriptionModule': {'briefSummary': 'The 2019-coronavirus disease (COVID-19), caused by SARS-CoV-2, was identified as the source of pneumonia cases in Wuhan city in China. It rapidly spread worldwide and was declared by WHO as a pandemic. COVID-19 vaccines are expected to be the breakthrough in controlling the pandemic. However, studies performed only in healthy adults, and specifically excluded patients who were under immunomodulatory/biologic therapy, thus excluding patients with chronic inflammatory diseases (IBD). In this study we wish to understand vaccine efficacy and immunological response in IBD patients.', 'detailedDescription': 'Overall Aims:\n\n1. To assess the immune response to COVID-19 vaccination in patients with IBD.\n2. Comparing the short and long term immune response to vaccination among subgroups receiving different therapies.\n3. To evaluate the different variables affecting immunity of these patients.\n4. To assess adverse reactions to COVID-19 vaccines and IBD related complications.\n\nSpecifically:\n\n1. To assess serologic response to COVID-19 vaccine(s) in patients with IBD treated with anti-TNF agents (+/- immunomodulators) compared to\n\n 1. Healthy controls\n 2. Patients with IBD not treated with anti-TNF (+/- immunomodulators)\n2. To characterize serologic response: seroconversion, seroprotection and persistence of COVID-19 vaccine(s) in patients with IBD\n3. To identify factors associated with serologic response\n4. Side effects to vaccines\n5. IBD exacerbation compared to activity at baseline\n6. Symptomatic COVID-19'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'IBD patients and healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Adults \\>18 years of age 2. Patients with either Crohn's disease, ulcerative colitis, ileostomy, pouch 3. Not vaccinated to COVID-19 \\[i.e. before 2 mRNA Pfizer vaccines provided, or before any vaccine provided as one injection 4. Ability to attend follow up visits 5. Ability to understand and sign an informed consent form\n\nExclusion Criteria:\n\n* 1\\. Pregnant women"}, 'identificationModule': {'nctId': 'NCT05067959', 'briefTitle': 'Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases', 'orgStudyIdInfo': {'id': '1072-20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IBD patients', 'description': "patients with IBD (Chron's disease, Ulcerative colitis, IBD-Unspecify). patients will be divided into two sub-groups: IBD patients on anti-TNF therapy IBD patients on any other therapy", 'interventionNames': ['Biological: Covid-19 vaccine']}, {'label': 'Controls', 'description': 'healthy volunteers', 'interventionNames': ['Biological: Covid-19 vaccine']}], 'interventions': [{'name': 'Covid-19 vaccine', 'type': 'BIOLOGICAL', 'description': 'blood tests and questioners before 1st vaccine, 3 weeks before 2nd vaccine, 4 weeks after 2nd vaccine, 6 months after 1st vaccine, and 12 months after 2nd vaccine', 'armGroupLabels': ['Controls', 'IBD patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, {'name': 'Emek Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Gasteroenterology Division', 'investigatorFullName': 'IRIS DOTAN', 'investigatorAffiliation': 'Rabin Medical Center'}}}}