Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT05633927
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2022-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Humoral and Cellular Immunity Against SARS-COV-2 Vaccine in HIV-infected Patients Immunosuppressed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-09', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibodies', 'timeFrame': '24 months', 'description': 'Analyse the percentage of subjects with SARS-CoV-2-specific IgG after 1, 6, and 12 months after complete vaccination regimen in HIV-infected subjects and ≤200 vs ≥350 CD4/μL. And to analyse the percentage of subjects with specific T and memory B lymphocyte response against SARS-CoV-2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV-2 RNA Vaccines', 'HIV Infection']}, 'referencesModule': {'references': [{'pmid': '37006309', 'type': 'RESULT', 'citation': 'Lopez-Cortes LF, Saborido-Alconchel A, Trujillo-Rodriguez M, Serna-Gallego A, Llaves-Flores S, Munoz-Muela E, Perez-Santos MJ, Lozano C, Mejias-Trueba M, Roca C, Espinosa N, Gutierrez-Valencia A. Humoral and cellular immunity to SARS-COV-2 after vaccination with mRNA vaccines in PLWH with discordant immune response. Influence of the vaccine administered. Front Immunol. 2023 Mar 15;14:1129753. doi: 10.3389/fimmu.2023.1129753. eCollection 2023.'}], 'seeAlsoLinks': [{'url': 'https://www.frontiersin.org/articles/10.3389/fimmu.2023.1129753/full', 'label': 'Related Info'}, {'url': 'http://www.frontiersin.org/articles/10.3389/fimmu.2023.1129753/full', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Prospective, non-equality, cohort study, where investigators propose to analyze humoral and cellular immunity after two doses of SARS-CoV-2 RNA vaccines in HIV-infected participants severely immunosuppressed.\n\nA total of 92 HIV-infected subjects over 18 years old with ≤200 CD4/μl (experimental group; n=46) and ≥ 350 CD4/μl (as control group; n=46) who have completed two doses vaccination against SARS-CoV-2 will be included in the study.\n\nPrimary Objectives:\n\n* To analyze the percentage of participants with SARS-CoV-2-specific IgG after 1, 6, and 12 months after vaccination in subjects with ≤200 vs ≥350 CD4/μL by electrochemiluminescence immunoassay (Elecsys® Anti-SARS-CoV-2. Roche Diagnostics).\n* To analyze the percentage of subjects with specific T and memory B lymphocyte response against SARS-CoV-2 after 1, 6, and 12 months after vaccination with \\<200 vs ≥350 CD4/μL. Multiparametric flow cytometry in peripheral blood mononuclear cells (PBMCs) will be performed to detect the production of cytokines (IL-2, TNF-α and IFN-γ), cytolytic (perforin and granzyme B) and degranulation (CD107a) molecules from T cells, as well as to identify memory B cells specific to SARS-CoV-2 IgG+.\n\nSecondary Objectives: To analyze in participants with \\<200 vs ≥350 CD4/μl after 1, 6, and 12 months after vaccination:\n\n* Quantification of specific IgG titers against SARS-CoV-2\n* The association of the T response to SARS-CoV-2 with humoral response parameters.\n* The association of the T response against SARS-CoV-2 with other parameters of immune activation, inflammation and immunosenescence. The phenotypes of maturation (CD45RA and CD27), activation (HLA-DR and CD38), senescence (CD57+CD28-) and markers of immune exhaustion (TIGIT, LAG-3, TIM-3 and PD-1) in CD4 and CD8 lymphocytes T will be determined by multiparametric flow cytometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study was designed as a cohort study comparing the immune response after vaccination of HIV-infected subjects with the hypothesis that subjects with ≤200 CD4/μL will have a worse response than those with CD4 count ≥ 350/μL.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. HIV-infected subjects over 18 years old and ≤200 CD4/μl who have completed vaccination against SARS-CoV-2.\n2. HIV-infected subjects with ≥350 CD4/μl who have completed vaccination against SARS-CoV-2 matched by age and sex as control group.\n3. Sign the informed consent.\n\nExclusion Criteria:\n\n1. Neoplastic or autoimmune disease known.\n2. Treatment with steroids, immunomodulators, interferon, chemotherapy or any pathology that may impact immunological parameters after vaccination against SARS-CoV-2.\n3. Active infections at the time of sampling.'}, 'identificationModule': {'nctId': 'NCT05633927', 'briefTitle': 'Humoral and Cellular Immunity Against SARS-COV-2 Vaccine in HIV-infected Patients Immunosuppressed', 'organization': {'class': 'OTHER', 'fullName': 'Hospitales Universitarios Virgen del Rocío'}, 'officialTitle': 'Prospective Study to Evaluate the Persistence and Characteristics of Humoral and Cellular Immunity Against SARS-COV-2 After Vaccination in HIV-infected Patients Severely Immunosuppressed', 'orgStudyIdInfo': {'id': 'CoVa-VIH-2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-immunological responder', 'description': 'Patients who start ART with \\<350 CD4+ T cells, maintaining undetectable viral load, and increasing \\<200 CD4+ T cell count after 18 months of follow-up.', 'interventionNames': ['Biological: SARS-CoV-2 Vaccine']}, {'label': 'Immunological responder', 'description': 'Patients with \\>350 CD4+ T cells', 'interventionNames': ['Biological: SARS-CoV-2 Vaccine']}], 'interventions': [{'name': 'SARS-CoV-2 Vaccine', 'type': 'BIOLOGICAL', 'description': 'Analyse humoral and cellular response to SARS-CoV-2 Vaccine.', 'armGroupLabels': ['Immunological responder', 'Non-immunological responder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Virgen del Rocio University Hospital', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Luis F. Lopez-Cortes', 'investigatorAffiliation': 'Hospitales Universitarios Virgen del Rocío'}}}}