Projectdetails

of


A prospective, controlled, multicenter cohort study by the REnal patients COVID-19 VACcination (RECOVAC) consortium

Keywords:
renal disease COVID-19 SARS-CoV-2 vaccination

Researchers:
Prof. dr. R.T. Gansevoort
dr. J.S.F. Sanders
A. L. Messchendorp

Nature of the research:
Efficacy and safety of COVID-19 vaccination in renal patients

Fields of study:
immunology virology nephrology

Background / introduction
Patients with severely decreased kidney function, patients treated by dialysis and patients after kidney transplantation can be considered very vulnerable for coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome
coronavirus-2 (SARS-CoV-2). Consequently, the availability of an effective and safe vaccine is of great importance for these patients.
Various vaccines against SARS-CoV-2 have recently become available. However, patients treated by dialysis and patients after
kidney transplantation were excluded from participation in almost all vaccination studies, while there are concerns that in these patients vaccinations may be less effective.
Research question / problem definition
We have established the RECOVAC(REnal patients COVID-19 VACcination) consortium with the aim to study the efficacy and safety of SARS-CoV-2 vaccination in patients with severely decreased kidney function, patients treated by dialysis and patients after kidney transplantation.

HYPOTHESIS
We hypothesize that SARS-CoV-2 vaccination is effective and safe in patients with severely decreased kidney function, patients
treated by dialysis and patients after kidney transplantation.
Workplan
We will investigate the efficacy and safety of SARS-CoV-2 vaccination in these patients in two complementary studies. The first
study is entitled RECOVAC IR (Immune Response), the second study is entitled RECOVAC LESS CoV-2 (Long-term Efficacy
and Safety of SARS-CoV-2 vaccination).

RECOVAC IR
Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with CKD stages 4/5, on dialysis or alive
with a kidney transplant as compared to controls
Study design: prospective, controlled multicenter study
Study population: 175 patients with CKD stages 4/5 (eGFR < 30 ml/min/1.73m2), 175 on dialysis , 300 alive with a kidney
transplant and 200 controls (partners or siblings of patients)
Intervention: After SARS-CoV-2 vaccination according to standard of care, blood will be drawn at 5 different time points
(baseline, prior to 2nd vaccination and at day 28, month 6 and year 1 after 2nd vaccination).
Outcome measures and data analysis: The primary endpoint is the antibody based immune response on day 28 after the
second vaccination. Participants will be classified as responders or non-responders. The percentage of responders of each
patient cohort will be compared with the percentage responders in the control group. Safety is a secondary endpoint which will
be reported in terms of percentage of solicited local and systemic adverse events (AEs) graded according to severity. Other
secondary endpoints include longevity of the immune response at 6 and 12 months and levels of SARS-CoV-2 specific T and
B cell responses.
RECOVAC LESS CoV-2 registry study
Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients on dialysis or after kidney transplantation
during two years follow-up after vaccination.
Study design: prospective multicenter observational cohort study.
Study population: all Dutch patients on dialysis or after kidney transplantation with data registered in the Dutch Dialysis registry
(RENINE) or the Dutch national kidney transplant registry (NOTR).
Outcome measures and data analysis: The primary endpoint is the efficacy of SARS-CoV-2 vaccination as assessed by the
incidence of COVID-19 in patients on dialysis and patients after kidney transplantation who received SARS-CoV-2 vaccination.
Secondary endpoints are the safety of SARS-CoV-2 vaccination as determined among others by incidence of a combined
endpoint of mortality and hospitalization, adverse events of specific interest, presence of HLA-antibodies in dialysis patients on
the waiting list for a first kidney transplantation, and acute rejection or graft failure in patients after kidney transplantation.
The incidence of these endpoints will be compared, if applicable, to those in the general population who are vaccinated, to
patients on dialysis or after kidney transplantation who are not vaccinated. The endpoints will also be compared between
recipients of different vaccines within the dialysis and kidney transplantation groups.
Together these two studies will provide valuable data on the efficacy and safety of SARS-CoV-2 vaccination in vulnerable
patients with kidney disease.
References
Gansevoort RT, Hilbrands LB. CKD is a key risk factor for COVID-19 mortality. Nat Rev Nephrol.
2020;16:705-706.

Hodgson SH. Lancet Infect Dis. What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. 2020 Oct 27:S1473-3099(20)30773-8. doi:
10.1016/S1473-3099(20)30773-8.

ERA-EDTA Council and the ERACODA Working Group: Chronic kidney disease is the key risk factor for
severe COVID-19. A call to action by the European Renal Association. Nephrology Dialysis Transplantation
2020 Dec 19. doi: 10.1093/ndt/gfaa314.
Kotton CN. Immunization after kidney transplantation-what is necessary and what is safe? Nat Rev
Nephrol. 2014;10:555-62.
Mahase E. Covid-19: Vaccine candidate may be more than 90% effective, interim results indicate. BMJ.
2020 Nov 9;371:m4347. doi: 10.1136/bmj.m4347
Noordzij M, ERACODA: the European database collecting clinical information of patients on kidney
replacement therapy with COVID-19 Nephrol Dial Transplant. 2020 Dec 4;35(12):2023-2025. doi:
10.1093/ndt/gfaa179.
Reddy S, Chitturi C, Yee J. Vaccination in Chronic Kidney Disease. Adv Chronic Kidney Dis. 2019;26:72-
78.
Williamson EJ et al, Factors associated with COVID-19-related death using OpenSAFELY. Nature
2020;584:430-436
Gezondheidsraad. Strategieën voor COVID-19-vaccinatie. Den Haag: Gezondheidsraad, 2020;
publicatienr. 2020/23.
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