Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-01-01 @ 1:57 AM
Study NCT ID:
NCT05074706
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2021-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Immune Response to Sars-Covid-19 Vaccines in Haematological Patients: Prospective Single Center Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Peripheral Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-23', 'studyFirstSubmitDate': '2021-10-05', 'studyFirstSubmitQcDate': '2021-10-05', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of seroconversion in hematological patients who received a mRNA SARS-CoV-2 vaccine', 'timeFrame': 'Between 30 and 60 days after the administration of the second vaccine dose', 'description': 'Seroconversion is defined as a post-vaccination SARS-CoV-2 IgG antibody titer \\>33.8 Binding Anticorpal Unit (BAU)/ml.'}], 'secondaryOutcomes': [{'measure': 'To compare the seroconversion rate in haematological patients versus healthy subjects.', 'timeFrame': 'Between 30 and 60 days after the administration of the second vaccine dose', 'description': 'Time adjusted rate of seroconversion after vaccination in hematological patient and healthy population.'}, {'measure': 'To correlate the rate of seroconversion in hematological patients to the specific haematological diseases.', 'timeFrame': 'Between 30 and 60 days after the administration of the second vaccine dose', 'description': 'Rate of seroconversion per type of haematological condition'}, {'measure': 'To correlate the rate of seroconversion to previous therapies', 'timeFrame': 'Between 30 and 60 days after the administration of the second vaccine dose', 'description': 'Rate of seroconversion per specific treatment.'}, {'measure': 'To assess the efficacy of vaccine by estimating how many patients will be infected by SARS-CoV-2 in the 9 months after the administration of the second vaccine dose.', 'timeFrame': 'Within 9 months after the administration of the second vaccine dose', 'description': 'Rate of patients with a positive RT-PCR-SARS-CoV-2 test in the 9 months after the administration of the second vaccine dose'}, {'measure': 'To analize T-cell response in those patients who will result negative for specific antibodies anti-Sars-Cov-2 after two doses of mRNA SARS-Cov-2 vaccination', 'timeFrame': 'Within 9 months after the administration of the second vaccine dose', 'description': 'Rate of patients with a positive QuantiFERON-SARS-CoV-2 test after the demonstration of seroconversion failure until the end of the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['serocoversion', 'COVID vaccination', 'cellular immunity', 'Sars-Cov-2 IgG antibodies', 'QuantiFERON-SARS-CoV-2 test'], 'conditions': ['Hematologic Diseases']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to investigate the humoral immune response to COVID-19 vaccines in haematological patients, by testing SARS-CoV-2 seroconversion', 'detailedDescription': 'This single-center prospective study will enroll approximately 700 hematologic patients who access to Haematological Division (San Gerardo Hospital, Monza, Italy) in order to perform their routine blood tests to monitor their hematological conditions. Evaluation of Sars-Cov-2 IgG specific antibodies will be performed on left-over biological material (serum or plasma) collected during routine blood tests run between 30 and 60 days after the administration of the second vaccine dose.\n\nFurthermore, in each patient who has failed seroconversion (absence of specific antibodies for circulation), his cellular immune response will be assessed using an additional blood sample collected during routine blood tests.\n\nThese samples will be collected within 9 months of the completion of the vaccination series and will be used to evaluate the plasma INF-γ release using QuantiFERON SARS-CoV-2 test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Haematological patients followed at the Haematological Division, San Gerardo Hospital, Monza, Italy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated EC-approved informed consent\n* Hematological disease defined according to World Health Organization (WHO) criteria\n* Female or male, 18 years of age or older\n* ECOG performance status 0-3\n* Willingness and ability to comply with routine clinical practice and study procedures\n* Regular vaccination against SARS-CoV-2 according to Italian Haematological Society (SIE) guidelines/recommendations (Version 2.0, 20 April, 2021).\n* Routine blood test planned between 30 and 60 days after administration of the second vaccine dose according to regular hematological follow up.\n* Routine blood test planned no later than 9 months after the completion of the vaccination series (only in case of absence of circulation specific antibodies).\n\nExclusion Criteria:\n\n* Preventive vaccination against SARS-CoV-2 not administered according to Italian Haematological Society (SIE) guidelines/recommendations (Version 2.0, 20 April, 2021)\n* Evidence of previous infection with the SARS-Cov-2 virus.\n* Routine blood test not planned between 30 and 60 days after administration of the second vaccine dose.\n* Routine blood test not planned within 9 months after the completion of the vaccination series (only in case of absence of circulation specific antibodies).'}, 'identificationModule': {'nctId': 'NCT05074706', 'acronym': 'Hema-C19-Vax', 'briefTitle': 'Evaluation of the Immune Response to Sars-Covid-19 Vaccines in Haematological Patients: Prospective Single Center Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Milano Bicocca'}, 'officialTitle': 'Evaluation of the Immune Response to Sars-Covid-19 (Cov-2) Vaccines in Haematological Patients: Prospective Single Center Study', 'orgStudyIdInfo': {'id': 'Hema-C19-Vax'}}, 'armsInterventionsModule': {'interventions': [{'name': 'IgG antibodies to Sars-Cov-2', 'type': 'BIOLOGICAL', 'otherNames': ['Blood serum SARS-CoV-2 IgG'], 'description': 'Samples will be collected between 30 and 60 days after second vaccine dose.'}, {'name': 'QuantiFERON SARS-CoV-2 test', 'type': 'BIOLOGICAL', 'otherNames': ['Plasma INF-γ'], 'description': 'Samples will be collected within 9 months after completion of the vaccination series'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20900', 'city': 'Monza', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'San Gerardo Hospital', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}], 'overallOfficials': [{'name': 'Carlo Gambacorti Passerini, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'San Gerardo Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milano Bicocca', 'class': 'OTHER'}, 'collaborators': [{'name': 'San Gerardo Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}