Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-31 @ 6:37 PM
Study NCT ID:
NCT04888793
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2021-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2021-05-09', 'studyFirstSubmitQcDate': '2021-05-09', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine', 'timeFrame': '8 to12 weeks after Coronavac vaccine'}], 'secondaryOutcomes': [{'measure': 'Neutralizing geometric mean titers 8 to12 weeks after Coronavac vaccine', 'timeFrame': '8 to12 weeks after Coronavac vaccine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'COVID-19 Vaccines']}, 'referencesModule': {'references': [{'pmid': '35255140', 'type': 'DERIVED', 'citation': 'Balcells ME, Le Corre N, Duran J, Ceballos ME, Vizcaya C, Mondaca S, Dib M, Rabagliati R, Sarmiento M, Burgos PI, Espinoza M, Ferres M, Martinez-Valdebenito C, Ruiz-Tagle C, Ortiz C, Ross P, Budnik S, Solari S, Vizcaya MLA, Lembach H, Berrios-Rojas R, Melo-Gonzalez F, Rios M, Kalergis AM, Bueno SM, Nervi B. Reduced Immune Response to Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in a Cohort of Immunocompromised Patients in Chile. Clin Infect Dis. 2022 Aug 24;75(1):e594-e602. doi: 10.1093/cid/ciac167.'}]}, 'descriptionModule': {'briefSummary': 'Despite COVID-19 pandemic having started more than one year ago, there are still limited treatment options for these patients, and over 145 million cases and 3 millions deaths have ensued worldwide. Fortunately, SARSCoV2 vaccines have been developed at an unprecedented pace. While the vaccination programs are still ongoing, early reports on efficacy are mainly centered on healthy population. In Chile most people have received the inactivated Coronavac vaccine. Data on the immune response after vaccination in immunocompromised patients is lacking. Therefore, this study aims to evaluate the immune response after Coronavac vaccine in 5 cohorts of immunocompromised patients and healthy controls. We will include patients with cancer, HIV, solid organ transplant and patients receiving immunomodulatory agents for rheumatic diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving care at the Red de Salud UC Christus in Santiago, Chile will be invited.', 'healthyVolunteers': True, 'eligibilityCriteria': "General Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group \\< 3\n* Vaccination with 2 doses of Coronavac vaccine\n\nGeneral Exclusion Criteria:\n\n* Previous SARS-CoV-2 infection\n* Vaccination with Coronavac more than 12 weeks before informed consent\n* Intravenous immunoglobulin therapy 60 days before informed consent\n* Any condition, that could interfere with the participant's participation during the study in the opinion of the treating investigator.\n\nCancer Cohort\n\nInclusion Criteria:\n\n* Diagnosis of cancer in the previous 5 years (consistent biopsy is required).\n* Life expectancy more than 12 weeks\n\nExclusion Criteria:\n\n* Bone marrow transplant, solid organ recipient, HIV, immunosuppressant treatment for other condition.\n\nBone Marrow Transplant Cohort\n\nInclusion Criteria:\n\n* Bone marrow transplant between January 2019 and December 2020\n\nExclusion Criteria:\n\n* Other cancer diagnosis during the last 5 years, solid organ recipient, HIV, immunosuppressant treatment for other condition.\n\nSolid Organ Recipient Cohort:\n\nInclusion Criteria:\n\n* Liver, kidney or heart transplant between January 2019 and December 2020\n* Active immunosuppressant treatment\n\nExclusion Criteria:\n\n\\- Cancer diagnosis during the last 5 years, bone marrow transplant, immunosuppressant treatment for other condition, HIV\n\nHIV Cohort:\n\nInclusion Criteria:\n\n* CD4 \\<= 500 cels/mm3 documented one year before study enrollment\n* Active antiretroviral therapy\n* Viral load \\< 200 copies/ml\n\nExclusion Criteria:\n\n* Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ recipient, immunosuppressant treatment.\n\nRheumatic Disease Cohort\n\nInclusion Criteria:\n\n* Diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, relapsing polychondritis, Behcet disease or juvenile idiopathic arthritis\n* Chronic immunomodulatory treatment with anti-TNF, anti-IL6 or anti-IL17 agents\n\nExclusion Criteria:\n\n* Treatment with more than one biological agent.\n* Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ recipient, HIV diagnosis."}, 'identificationModule': {'nctId': 'NCT04888793', 'briefTitle': 'Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study', 'orgStudyIdInfo': {'id': '210405014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer Patients on active treatment', 'interventionNames': ['Diagnostic Test: Serologic immune response evaluation']}, {'label': 'Bone marrow transplant patients', 'interventionNames': ['Diagnostic Test: Serologic immune response evaluation']}, {'label': 'Solid organ transplant recipients', 'interventionNames': ['Diagnostic Test: Serologic immune response evaluation']}, {'label': 'HIV patients', 'interventionNames': ['Diagnostic Test: Serologic immune response evaluation']}, {'label': 'Rheumatic disease patients', 'interventionNames': ['Diagnostic Test: Serologic immune response evaluation']}, {'label': 'Healthy controls', 'interventionNames': ['Diagnostic Test: Serologic immune response evaluation']}], 'interventions': [{'name': 'Serologic immune response evaluation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Detection of total and neutralizing antibodies against SARS-CoV-2', 'armGroupLabels': ['Bone marrow transplant patients', 'Cancer Patients on active treatment', 'HIV patients', 'Healthy controls', 'Rheumatic disease patients', 'Solid organ transplant recipients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'country': 'Chile', 'facility': 'Red de Salud UC Christus', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Elvira Balcells, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pontificia Universidad Catolica de Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}