Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-28 @ 9:56 PM
Study NCT ID:
NCT04944433
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2021-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of the Coronavirus Disease 2019 Vaccine in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 950}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-04', 'studyFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2021-06-28', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine', 'timeFrame': 'one year', 'description': 'Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine'}, {'measure': 'To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 21 days, at 40 days and at 120 days after immunization', 'timeFrame': 'one year', 'description': 'To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 21 days, at 40 days and at 120 days after immunization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Seroepidemiologic Studies', 'Renal Dialysis', 'Coronavirus disease 2019 Vaccines'], 'conditions': ['Coronavirus Disease 2019 Vaccines', 'Renal Dialysis']}, 'referencesModule': {'references': [{'pmid': '32896291', 'type': 'RESULT', 'citation': 'Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, Grousova DM, Erokhova AS, Kovyrshina AV, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Lubenets NL, Egorova DA, Shmarov MM, Nikitenko NA, Morozova LF, Smolyarchuk EA, Kryukov EV, Babira VF, Borisevich SV, Naroditsky BS, Gintsburg AL. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet. 2020 Sep 26;396(10255):887-897. doi: 10.1016/S0140-6736(20)31866-3. Epub 2020 Sep 4.'}, {'pmid': '33545094', 'type': 'RESULT', 'citation': 'Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Egorova DA, Shmarov MM, Nikitenko NA, Gushchin VA, Smolyarchuk EA, Zyryanov SK, Borisevich SV, Naroditsky BS, Gintsburg AL; Gam-COVID-Vac Vaccine Trial Group. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021 Feb 20;397(10275):671-681. doi: 10.1016/S0140-6736(21)00234-8. Epub 2021 Feb 2.'}, {'pmid': '33306989', 'type': 'RESULT', 'citation': "Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8."}, {'pmid': '27836435', 'type': 'RESULT', 'citation': 'Di Pasquale A, Bonanni P, Garcon N, Stanberry LR, El-Hodhod M, Tavares Da Silva F. Vaccine safety evaluation: Practical aspects in assessing benefits and risks. Vaccine. 2016 Dec 20;34(52):6672-6680. doi: 10.1016/j.vaccine.2016.10.039. Epub 2016 Nov 8.'}, {'pmid': '31583123', 'type': 'RESULT', 'citation': "Herve C, Laupeze B, Del Giudice G, Didierlaurent AM, Tavares Da Silva F. The how's and what's of vaccine reactogenicity. NPJ Vaccines. 2019 Sep 24;4:39. doi: 10.1038/s41541-019-0132-6. eCollection 2019."}, {'pmid': '28728074', 'type': 'RESULT', 'citation': 'Mitchell TC, Casella CR. No pain no gain? Adjuvant effects of alum and monophosphoryl lipid A in pertussis and HPV vaccines. Curr Opin Immunol. 2017 Aug;47:17-25. doi: 10.1016/j.coi.2017.06.009. Epub 2017 Jul 17.'}, {'pmid': '33558753', 'type': 'RESULT', 'citation': 'Windpessl M, Bruchfeld A, Anders HJ, Kramer H, Waldman M, Renia L, Ng LFP, Xing Z, Kronbichler A. COVID-19 vaccines and kidney disease. Nat Rev Nephrol. 2021 May;17(5):291-293. doi: 10.1038/s41581-021-00406-6. Epub 2021 Feb 8.'}, {'pmid': '33762353', 'type': 'RESULT', 'citation': 'Heldman MR, Limaye AP. SARS-CoV-2 Vaccines in Kidney Transplant Recipients: Will They Be Safe and Effective and How Will We Know? J Am Soc Nephrol. 2021 May 3;32(5):1021-1024. doi: 10.1681/ASN.2021010023. Epub 2021 Mar 24. No abstract available.'}, {'pmid': '18162092', 'type': 'RESULT', 'citation': 'Scharpe J, Evenepoel P, Maes B, Bammens B, Claes K, Osterhaus AD, Vanrenterghem Y, Peetermans WE. Influenza vaccination is efficacious and safe in renal transplant recipients. Am J Transplant. 2008 Feb;8(2):332-7. doi: 10.1111/j.1600-6143.2007.02066.x. Epub 2007 Dec 19.'}, {'pmid': '33208402', 'type': 'RESULT', 'citation': 'Labriola L, Scohy A, Seghers F, Perlot Q, De Greef J, Desmet C, Romain C, Morelle J, Yombi JC, Kabamba B, Rodriguez-Villalobos H, Jadoul M. A Longitudinal, 3-Month Serologic Assessment of SARS-CoV-2 Infections in a Belgian Hemodialysis Facility. Clin J Am Soc Nephrol. 2021 Apr 7;16(4):613-614. doi: 10.2215/CJN.12490720. Epub 2020 Nov 18. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines', 'label': 'World Health Organization.Coronavirus disease 2019 vaccines.'}, {'url': 'https://www.argentina.gob.ar/noticias/registro-de-emergencia-del-producto-covid-19-vacuna-astrazeneca', 'label': 'Emergency registration of the product "Coronavirus disease 2019 Vaccine AstraZeneca". 2020. Argentina'}, {'url': 'https://www.argentina.gob.ar/sites/default/files/coronavirus-vacuna-plan-estrategico-vacunacion-covid-19-diciembre-2020.pdf', 'label': 'Ministry of Health, Argentina. Strategic Plan for vaccination against Coronavirus disease 2019 in Argentina 2020'}, {'url': 'https://sisa.msal.gov.ar/sisadoc/docs/050203/nomivac_home.jsp', 'label': 'Ministry of Health, Argentina. Integrated Argentine Health Information System. 2020.'}]}, 'descriptionModule': {'briefSummary': 'It is unknown whether Coronavirus disease 2019 vaccines confer the same high level of protection in patients with kidney disease as reported for participants in recent trials, who were generally healthy. Objectives: To evaluate the safety and efficacy of Coronavirus disease 2019 vaccines in hemodialysis patients.', 'detailedDescription': 'Given the vulnerability of people with chronic kidney disease to Coronavirus 2019 , leading nephrology societies such as the National Kidney Federation and the American Kidney Foundation have issued statements calling for prioritization of these patients for vaccination. It is unknown whether Coronavirus disease 2019 vaccines confer the same high level of protection in patients with kidney disease as reported for participants in recent trials, who were generally healthy.\n\nObjectives:\n\n1. Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine\n2. Determine the levels of Immunoglobulin G antibodies in patients who received a Coronavirus disease 2019vaccine between the time before the first dose, at 21 days, at 40 days and at 120 days after immunization.\n\nMethods Design: Multicenter, observational and analytical study of a prospective cohort of hemodialysis patients 18 years and older who received immunization with a Coronavirus disease 2019 vaccine in the Autonomous City of Buenos Aires in a vaccination plan.\n\nAnalysis The proportion of patients with Adverse events presumably attributable to vaccination and immunization will be estimated with its 95% confidence interval. The immunoglobulin G titer for coronavirus type 2 causing severe acute respiratory syndrome will be compared using Generalized Estimating Equations models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hemodialysis patients in an immunization plan with a COVID-19 vaccine from the hemodialysis centers of the Autonomous City of Buenos Aires', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age on hemodialysis in an immunization plan with a Coronavirus disease 2019 vaccine.\n\nExclusion Criteria:\n\n* Contraindication to receive the vaccine.'}, 'identificationModule': {'nctId': 'NCT04944433', 'briefTitle': 'Safety and Efficacy of the Coronavirus Disease 2019 Vaccine in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Italiano de Buenos Aires'}, 'officialTitle': 'Safety and Efficacy of the Coronavirus Disease 2019 Vaccine in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '7412'}}, 'contactsLocationsModule': {'locations': [{'zip': '1121A6B', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Universidad de Buenos Aires Facultad de Medicina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Guillermo IP Rosa Diez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Jorge SI Geffner', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Buenos Aires'}, {'name': 'Fernando SI Lombi', 'role': 'STUDY_CHAIR', 'affiliation': 'Sociedad Argentina de Nefrología'}, {'name': 'Marina SI Papaginovic', 'role': 'STUDY_CHAIR', 'affiliation': 'Sociedad Argentina de Nefrología'}, {'name': 'Ricardo SI Heguilen', 'role': 'STUDY_CHAIR', 'affiliation': 'Sociedad Argentina de Nefrología'}, {'name': 'Luciana Fernandez SI Paganti', 'role': 'STUDY_CHAIR', 'affiliation': 'Sociedad Argentina de Nefrología'}, {'name': 'Soledad SI Crucelegui', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Vanina SI Pagotto', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Italiano de Buenos Aires'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Italiano de Buenos Aires', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministerio de Salud de Ciudad Autónoma de Buenos Aires', 'class': 'OTHER_GOV'}, {'name': 'University of Buenos Aires', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'GUILLERMO JAVIER ROSA DIEZ', 'investigatorAffiliation': 'Hospital Italiano de Buenos Aires'}}}}