COVID-19 is associated with increased morbidity and mortality in kidney transplant recipients (KTR) and patients with chronic kidneydisease (CKD). Therefore, potential efficacious SARS-CoV-2 vaccination would be of great clinical importance in these patients.However, SARS-CoV-2 vaccination studies have excluded KTR and patients with CKD so-far and it is unknown how long a possible antibody response will endure. This will be the subject of this trial. MedDRA version: 23.1 Level: LLT Classificati
Conditions
Interventions
Trade Name: COVID-19 vaccine Moderna
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Single-stranded, 5’-capped messenger RNA (mRNA) encoding the viral spike (S) protein of S
Sponsors
RECOVAC consortium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Eligible for COVID-19 vaccination as described by the instructions of the manufacturer. 2. Age of 18 years or older 3. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained) 4. Either - eGFR =65 years) yes F.1.3.1 Number of subjects for this age range 4000
Exclusion criteria
Exclusion criteria: • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s). • Patients who opted out for research in the Santeon, RENINE and NOTR registries. • Patients who participate in the RECOVAC-IR study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - To assess the antibody response at 28 days after SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis and in patients after kidney transplantation - To assess durability of the antibody response at 6 months after SARS-CoV 2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis and in patients after kidney transplantation - To assess the safety of vaccination ;Main Objective: To assess the efficacy of SARS-CoV vaccination by the incidence of COVID-19 in patients with chronic kidney disease stage G4-G5, on dialysis and patients after kidney transplantation who received SARS-CoV-2 vaccination;Primary end point(s): The incidence of COVID-19 in a two years period after SARS- CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation.;Timepoint(s) of evaluation of this end point: Two years after SARS-CoV-2 vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Efficacy: o The antibody based immune response to vaccination against COVID-19 at day 28 after the second vaccination. o The durability of the antibody response at 6 months after SARS-CoV 2 vaccination • Safety: • Incidence of mortality • Incidence of adverse events of specific interest as defined by (inter)national authorities • Incidence of a combined endpoint of acute rejection or graft failure in patients after kidney transplantation • Incidence of HLA antibodies defined as calculated Panel Reactivity Antibodies (cPRA) > 5% in dialysis patients on the waiting list for their first kidney transplantation ;Timepoint(s) of evaluation of this end point: Antibody response: 28 days and 6 months after vaccination Other endpoints over a period of 2 years | — |
Countries
Netherlands
Contacts
Public Contactstudy coordinator
RECOVAC consoritum
Outcome results
None listed