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. 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.
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.
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).
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.