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Samenvatting
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In de RECOVAC studies onderzoeken wij de immuunrespons op COVID-19 vaccinatie in nierpatiënten.

De RECOVAC-immuunrespons (IR) studie heeft inmiddels aangetoond dat de antistofrespons in dialyse en CKD4/5 patiënten 28 dagen na vaccinatie niet minder was dan in controles. De antistofrespons in niertransplantatie patiënten was wel minder goed dan in controles, dit hing samen met het gebruik van de afweeronderdrukker MMF.

In de grotere RECOVAC antistof studie zijn 4868 nierpatiënten uitgenodigd voor een vingerprik, waarvan 4493 een bloedmonster en vragenlijst hebben ingestuurd na de tweede vaccinatie. In het ingestuurde bloed hebben wij antistoffen gemeten. Het gebruik van afweeronderdrukkers resulteerde ook in CKD4/5 en dialyse patiënten in lagere antistof hoeveelheden, al waren ze hoger dan in niertransplantatie patiënten. Vaccinatie met het Moderna vaccin (mRNA-1273) leidde tot een hogere antistofrespons dan vaccinatie met Pfizer.

 

Resultaten
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RECOVAC-IR studie

De antistofrespons in dialyse en CKD4-5 patiënten was niet-minder goed dan in controles. De antistofrespons in niertransplantatie patiënten was minder goed dan in controles, dit wordt met name veroorzaakt door gebruik van het afweeronderdrukkende medicijn MMF.

 

RECOVAC antistof studie

Gebruik van afweeronderdrukkende medicijnen zorgde ook in CKD4-5 en dialyse patiënten voor lagere antistof hoeveelheden, al zijn deze hoger dan in niertransplantatie patiënten. Moderna (mRNA-1273) leidde tot hogere antistofrespons dan vaccinatie met Pfizer (BNT162b)

Samenvatting van de aanvraag

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RESEARCH QUESTION

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.

 

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.

 

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.

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