The RECOVAC IR study: the immune response and safety of the mRNA-1273 COVID-19 vaccine in patients with chronic kidney disease, on dialysis or living with a kidney transplant

Kho, Marcia M. L.; Reinders, Marlies E.J.; Baan, Carla C.; Baarle, Debbie van; Bemelman, Fréderike J.; Diavatopoulos, Dimitri A.; Gansevoort, Ron T.; Klis, Fiona R.M. van der; Koopmans, Marion; Messchendorp, A. Lianne; Molen, Renate G. van der; Remmerswaal, Ester B. M.; Rots, Nynke Y.; Vart, Priya; Vries, Rory D de; Hilbrands, Luuk B.; Sanders, Jan-Stephan; Abrahams, Alferso C; Hemmelder, Marc H; Dam, Marc A.G.J. ten; Vries, Aiko P.J. de; Binnendijk, Rob van; Hartog, Gerco den; Bouwmans, Pim; Frölke, Sophie C; Malahe, S. Reshwan K.

doi:10.1093/ndt/gfab186

Cited by 39 publications

(41 citation statements)

References 17 publications

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“…The design of the RECOVAC Immune Response study has been published previously in detail. 10 The study was performed between February 1 and May 31, 2021, at the outpatient clinics of 4 university medical centers in the Netherlands (Amsterdam UMC, UMC Groningen, Radboudumc Nijmegen and Erasmus MC Rotterdam). Approval was obtained from the Dutch Central Committee on Research Involving Human Subjects (CCMO, NL76215.042.21) and the local ethics committees of the participating centers.…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2021

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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 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.

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Section: Methodsmentioning

confidence: 99%

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

et al. 2021

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“…A number of studies have examined the efficacy and safety of COVID-19 vaccines in patients with kidney diseases — including those on dialysis and kidney transplant recipients 129 , 130 . The Renal Patients COVID-19 Vaccination Immune Response (RECOVAC IR) study, which includes patients with CKD not on dialysis, is ongoing 131 . The available evidence indicates that kidney transplant recipients and patients on dialysis have an impaired response to vaccines compared with that in the general population 125 , 132 , 133 .…”

Section: Covid-19 Pharmacoepidemiology In Kidney Diseasementioning

confidence: 99%

COVID-19 and kidney disease: insights from epidemiology to inform clinical practice

Mahalingasivam

Iwagami

et al. 2022

Nat Rev Nephrol

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Over the course of the COVID-19 pandemic, numerous studies have aimed to address the challenges faced by patients with kidney disease and their caregivers. These studies addressed areas of concern such as the high infection and mortality risk of patients on in-centre haemodialysis and transplant recipients. However, the ability to draw meaningful conclusions from these studies has in some instances been challenging, owing to barriers in aspects of usual care, data limitations and problematic methodological practices. In many settings, access to SARS-CoV-2 testing differed substantially between patient groups, whereas the incidence of SARS-CoV-2 infection varied over time and place because of differences in viral prevalence, targeted public health policies and vaccination rates. The absence of baseline kidney function data posed problems in the classification of chronic kidney disease and acute kidney injury in some studies, potentially compromising the generalizability of findings. Study findings also require attentive appraisal in terms of the effects of confounding, collider bias and chance. As this pandemic continues and in the future, the implementation of sustainable and integrated research infrastructure is needed in settings across the world to minimize infection transmission and both prevent and plan for the short-term and long-term complications of infectious diseases. Registries can support the real-world evaluation of vaccines and therapies in patients with advanced kidney disease while enabling monitoring of rare complications.

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“…The response rate to COVID-19 vaccines in dialysis patients is reported to be between 64% and 97% [ 4 ]. While many studies report short-term antibody levels after vaccination [ 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 ], there are scarce data on the long-term antibody kinetics following COVID-19 vaccination, and clinical studies are ongoing [ 14 ]. One study reported waning antibody levels six months post vaccination [ 15 ].…”

Section: Introductionmentioning

confidence: 99%

Waning Humoral Response 3 to 6 Months after Vaccination with the SARS-COV-2 BNT162b2 mRNA Vaccine in Dialysis Patients

Berar-Yanay

Freiman

Shapira

et al. 2021

JCM

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Background and objectives: The short-term reported antibody response to SARS-COV-2 vaccination in dialysis patients is high, with a seroconversion response rate up to 97%. Data on the long-term durability of this response are scarce. Our objective was to characterize the long-term anti-spike antibody level in dialysis patients. Design, setting, participants, and measurements: In an observational study, we measured SARS-COV-2 anti-spike antibody levels in dialysis patients who completed 2 doses of the BNT162b2 mRNA SAR S-COV-2 vaccine at 1, 3 and 6 months after the second vaccine dose. We compared the response to dialysis patients who were infected with COVD-19 and to a control group of healthcare-employees. Results: One hundred and forty-two dialysis patients who had been vaccinated (ages 64 ± 11.9 years, 61% male), 33 dialysis patients who had COVID-19 infection (ages 54 ± 14.3 years, 55% male) and 104 individuals in the control group (ages 50 ± 12.2 years, 44% male) were included. The response rate in the vaccinated dialysis patients was 94%, 78% and 73% at 1, 3 and 6 months after the second vaccine dose. In the COVID-19 infected dialysis group and in the control group, the response rate remained at 100% over 6 months. The percentage of change in antibody levels between one and 6 months was −66% in the vaccinated dialysis group, −28% in the control group (p < 0.001) and +48% in dialysis patients who had been infected with COVID-19 (p < 0.001). A non-responder status at 6 months was associated with a lower albumin level. No serious adverse events following vaccination were reported. In conclusion: the initially high response rate to the BNT162b2 vaccine in dialysis patients decreases rapidly. Our results indicate that an early booster (3rd) dose, at three months after the second dose, may be advised for this population to preserve the humoral immunity.

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The RECOVAC IR study: the immune response and safety of the mRNA-1273 COVID-19 vaccine in patients with chronic kidney disease, on dialysis or living with a kidney transplant

Cited by 39 publications

References 17 publications

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

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

COVID-19 and kidney disease: insights from epidemiology to inform clinical practice

Waning Humoral Response 3 to 6 Months after Vaccination with the SARS-COV-2 BNT162b2 mRNA Vaccine in Dialysis Patients

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