1. The RECOVAC Immune-response Study: The Immunogenicity, Tolerability, and Safety of COVID-19 Vaccination in Patients With Chronic Kidney Disease, on Dialysis, or Living With a Kidney Transplant
- Author
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Priya Vart, Wouter B Mattheussens, Marion Koopmans, Gerco den Hartog, Dimitri A. Diavatopoulos, Luuk B. Hilbrands, Marlies E J Reinders, Djenolan van Mourik, Renate G. van der Molen, Celine Imhof, Marieke van der Heiden, Daryl Geers, C. Baan, Frederike J. Bemelman, Rory D. de Vries, Marcia M L Kho, S Reshwan K Malahe, Debbie van Baarle, Rob van Binnendijk, Ester B. M. Remmerswaal, Jan-Stephan F. Sanders, Corine H. GeurtsvanKessel, Ron T. Gansevoort, Nynke Y. Rots, A. Lianne Messchendorp, Sophie C Frölke, Internal Medicine, Virology, Nephrology, AII - Inflammatory diseases, APH - Aging & Later Life, Infectious diseases, Graduate School, Experimental Immunology, Groningen Institute for Organ Transplantation (GIOT), Groningen Kidney Center (GKC), Translational Immunology Groningen (TRIGR), and Cardiovascular Centre (CVC)
- Subjects
medicine.medical_specialty ,COVID-19 Vaccines ,medicine.medical_treatment ,lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4] ,All institutes and research themes of the Radboud University Medical Center ,SDG 3 - Good Health and Well-being ,Renal Dialysis ,Internal medicine ,Medicine ,Humans ,Prospective Studies ,Seroconversion ,Renal Insufficiency, Chronic ,Dialysis ,Transplantation ,Kidney ,business.industry ,Immunogenicity ,Vaccination ,Immunity ,COVID-19 ,medicine.disease ,Kidney Transplantation ,medicine.anatomical_structure ,Tolerability ,Cohort ,Renal disorders Radboud Institute for Health Sciences [Radboudumc 11] ,business ,Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5] ,Kidney disease ,2019-nCoV Vaccine mRNA-1273 - Abstract
BACKGROUND: In kidney patients COVID-19 is associated with severely increased morbidity and mortality. A comprehensive comparison of the immunogenicity, tolerability, and safety of COVID-19 vaccination in different cohorts of kidney patients and a control cohort is lacking.METHODS: This investigator driven, prospective, controlled multicenter study included 162 participants with chronic kidney disease (CKD) stages G4/5 (eGFR < 30 mL/min/1.73m2), 159 participants on dialysis, 288 kidney transplant recipients, and 191 controls. Participants received 2 doses of the mRNA-1273 COVID-19 vaccine (Moderna). The primary endpoint was seroconversion.RESULTS: Transplant recipients had a significantly lower seroconversion rate when compared with controls (56.9% versus 100%, P < 0.001), with especially mycophenolic acid, but also, higher age, lower lymphocyte concentration, lower eGFR, and shorter time after transplantation being associated with nonresponder state. Transplant recipients also showed significantly lower titers of neutralizing antibodies and T-cell responses when compared with controls. Although a high seroconversion rate was observed for participants with CKD G4/5 (100%) and on dialysis (99.4%), mean antibody concentrations in the CKD G4/5 cohort and dialysis cohort were lower than in controls (2405 [interquartile interval 1287-4524] and 1650 [698-3024] versus 3186 [1896-4911] BAU/mL, P = 0.06 and P < 0.001, respectively). Dialysis patients and especially kidney transplant recipients experienced less systemic vaccination related adverse events. No specific safety issues were noted.CONCLUSIONS: The immune response following vaccination in patients with CKD G4/5 and on dialysis is almost comparable to controls. In contrast, kidney transplant recipients have a poor response. In this latter, patient group development of alternative vaccination strategies are warranted.Supplemental visual abstract; http://links.lww.com/TP/C307.
- Published
- 2022