Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2026-04-18 @ 7:10 AM
Study NCT ID:
NCT05597761
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2022-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients (Auto-COVID-VACC)
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': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-Spike-IgG titers', 'timeFrame': 'At the end of each vaccination cycle (each cycle is 28 days)', 'description': 'Time to an adequate immune response according to the recent version of the COVID-19 vaccination standard after repeated mRNA vaccinations'}], 'secondaryOutcomes': [{'measure': 'BA.1-specific neutralizing antibody ID50 titers', 'timeFrame': 'At the end of each vaccination cycle (each cycle is 28 days)', 'description': 'Time to Omicron BA.1-specific neutralizing antibody ID50 titers ≥20/ml after repeated mRNA vaccinations'}, {'measure': 'Anti-Spike-1/2 IgG increase >33.8 BAU/ml', 'timeFrame': 'At the end of each vaccination cycle (each cycle is 28 days)', 'description': 'Time to anti-Spike-1/2 IgG increase \\>33.8 BAU/ml after repeated mRNA vaccinations in immunocompromised patients'}, {'measure': 'Decrease of BA.1-specific neutralizing antibody ID50 titers', 'timeFrame': 'Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks', 'description': 'Time to decrease of Omicron BA.1-specific neutralizing antibody ID50 titers \\<20/ml after last mRNA vaccine in successfully vaccinated patients'}, {'measure': 'Anti-Spike-1/2 IgG decrease ≤33.8 BAU/ml', 'timeFrame': 'Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks', 'description': 'Time to anti-Spike-1/2 IgG decrease ≤33.8 BAU/ml after last mRNA vaccine in successfully vaccinated patients'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'mRNA vaccination', 'Immunocompromised patients'], 'conditions': ['COVID-19', 'Adult', 'Immunocompromised Patients']}, 'referencesModule': {'references': [{'pmid': '40418566', 'type': 'DERIVED', 'citation': 'Cremer LM, Bethe U, Borchmann P, Di Cristanziano V, Gieselmann L, Grimm S, Hellmich M, Jakobs J, Nacov JA, Neuhann JM, Prattes J, Scheid C, Sprute R, Steger G, Stemler J, Mellinghoff SC, Cornely OA. Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients (Auto-COVID-VACC): Protocol for Multicenter Prospective Noninterventional Study. JMIR Res Protoc. 2025 May 26;14:e60675. doi: 10.2196/60675.'}]}, 'descriptionModule': {'briefSummary': 'This multicenter, prospective, non-interventional study aims to evaluate data on humoral and cellular immune response generated within the COVID-19 vaccination standard in immunocompromised patients.', 'detailedDescription': 'This study aims to analyze the immune response data generated within the procedures of the standard-of-care COVID-19 vaccination. for immunocompromised patients.\n\nAdditional blood will be drawn from the patients at each visit defined within the vaccination standard by using the same vein puncture as used for blood drawings of routine blood samples. Study related blood samples will be used for evaluation of T and B cell response to COVID-19 vaccinations.\n\nFor this study, no additional visits or invasive procedures will be performed in addition to the standard interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Immunocompromised patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient is vaccinated according to the recent version of the COVID-19 vaccination standard for immunocompromised patients.\n* Patient is 18 years of age or older at enrollment.\n* Written informed consent from patient has been obtained prior to any study related procedures\n\nExclusion criteria:\n\n• Patient is not vaccinated according to the recent version of the COVID-19 vaccination standard. Patient has a positive SARS-CoV-2 antigen test at the first visit.'}, 'identificationModule': {'nctId': 'NCT05597761', 'briefTitle': 'Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients (Auto-COVID-VACC)', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients (Auto-COVID-VACC)', 'orgStudyIdInfo': {'id': 'AUTO-COVID-VACC-4943'}}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV) Uniklinik der RWTH Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45147', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen Klinik für Hämatologie und Stammzellentransplantation', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Oliver A. Cornely, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Cologne, Internal Medicine I'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oliver Cornely, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZKS Köln', 'class': 'OTHER'}, {'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Oliver Cornely, MD', 'investigatorAffiliation': 'University of Cologne'}}}}