Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-30 @ 7:11 AM
Study NCT ID:
NCT05162456
Status:
UNKNOWN
Last Update Posted:
2021-12-17
First Post:
2021-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study in Patients After Organ Transplantation
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': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-15', 'studyFirstSubmitDate': '2021-12-15', 'studyFirstSubmitQcDate': '2021-12-15', 'lastUpdatePostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the anti-SARS-CoV-2 IgG antibody concentration 3 months after vaccination cycle with the BNT162b2 vaccine', 'timeFrame': '0-12 months', 'description': 'evaluation of anti-SARS-CoV-2 IgG antibody concentration 3 months after 2-dose vaccination with BNT162b2 vaccine'}], 'secondaryOutcomes': [{'measure': 'the anti-SARS-CoV-2 IgG antibody concentration 6, 9 and 12 months after two-dose vaccination cycle', 'timeFrame': '0-12 months', 'description': 'evaluation of anti-SARS-CoV-2 IgG antibody concentration at particular time points in 2-dose vaccination schedule'}, {'measure': 'the anti-SARS-CoV-2 IgG antibody concentration immediately before, 1 and 3 months after the third vaccine dose', 'timeFrame': '0-12 months', 'description': 'evaluation of anti-SARS-CoV-2 IgG antibody concentration at particular time points after 3rd dose of vaccine'}, {'measure': 'local and/or systemic adverse reactions after vaccination', 'timeFrame': '0-12 months', 'description': 'verification of any adverse events occurrence based on survey filled by participants on each visit'}, {'measure': 'confirmed COVID-19 after vaccination', 'timeFrame': '0-12 months', 'description': 'verification of COVID-19 based on survey filled by participants on each visit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV2 Infection', 'SARS-CoV2 Antibodies']}, 'descriptionModule': {'briefSummary': 'Great expectations to control the pandemic are placed in vaccines against COVID-19. Currently, the four COVID-19 vaccines approved in the European Union. The investigators designed a study assessing the anti-SARS-CoV-2 IgG antibody titer after vaccination cycle with the BNT162b2 vaccine in several time points relating these results to the COVID-19 history and severity of symptoms during the disease and after the first and second vaccine dose.', 'detailedDescription': 'The study includes patients of Antoni Jurasz University Hospital No.1 in Bydgoszcz after organ transplantation. To meet the inclusion criteria patients will have to be vaccinated with two doses of the BNT162b2 vaccine. The assessment of the anti-SARS-CoV-2 IgG antibody titer at several time points in each participant. Fresh serum samples were used to measure SARS-CoV-2 IgG on the Siemens Atellica system (Siemens Healthineers, Erlangen, Germany). Results of SARS-CoV-2 IgG were given as U/ml, whereby the cut-off for positivity was defined as ≥1.0 U/ml.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study patients of Antoni Jurasz University Hospital No.1 in Bydgoszcz who underwent organ transplantation.\n\nApproximately 250 adult participants are planned to be included in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent to study\n* Age ≥ 18 years\n* Receiving two doses of the BNT162b2 vaccine\n* patients post organ transplantation\n\nExclusion Criteria:\n\n* patients who did not complete 2-dose vaccination schedule\n* patients who received any other vaccine than BNT162b2\n* patients considered by investigator to be unable to cooperate'}, 'identificationModule': {'nctId': 'NCT05162456', 'acronym': 'DANTE-SIRIO 8', 'briefTitle': 'Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study in Patients After Organ Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Collegium Medicum w Bydgoszczy'}, 'officialTitle': 'Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination in Patients After Organ Transplantation (DANTE-SIRIO 8) Study', 'orgStudyIdInfo': {'id': 'DANTE-SIRIO 8'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'participants willing to receive a 3-dose vaccination schedule', 'description': 'participants willing to receive a 3-dose vaccination schedule', 'interventionNames': ['Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule']}, {'label': 'participants unwilling to receive a 3rd dose of vaccination', 'description': 'participants who received a 2-dose vaccination schedule, unwilling to receive a 3rd dose', 'interventionNames': ['Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule']}], 'interventions': [{'name': 'assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule', 'type': 'DIAGNOSTIC_TEST', 'description': 'evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule willing to receive a 3rd dose of vaccine', 'armGroupLabels': ['participants willing to receive a 3-dose vaccination schedule']}, {'name': 'assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule', 'type': 'DIAGNOSTIC_TEST', 'description': 'evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule unwilling to receive a 3rd dose of vaccine', 'armGroupLabels': ['participants unwilling to receive a 3rd dose of vaccination']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bydgoszcz', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Emilia Wojtal, MD', 'role': 'CONTACT', 'email': 'terenia4@interia.pl', 'phone': '+48 52 5854380'}], 'facility': 'Department of Transplantology and General Surgery, Dr. A. Jurasz University Hospital', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}], 'centralContacts': [{'name': 'Emilia Wojtal, MD', 'role': 'CONTACT', 'email': 'terenia4@interia.pl', 'phone': '+48 52 5854380'}], 'overallOfficials': [{'name': 'Zbigniew Włodarczyk, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Collegium Medicum w Bydgoszczy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Collegium Medicum w Bydgoszczy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jacek Kubica', 'investigatorAffiliation': 'Collegium Medicum w Bydgoszczy'}}}}