Abstract
BACKGROUND: COVID-19 is associated with increased morbidity and mortality in patients with chronic kidney disease (CKD) stages G4-G5, on dialysis or after kidney transplantation (kidney replacement therapy, KRT). SARS-CoV-2 vaccine trials do not elucidate if SARS-CoV-2 vaccination is effective in these patients. Vaccination against other viruses is known to be less effective in kidney patients. Our objective is to assess the efficacy and safety of various types of SARS-CoV-2 vaccinations in patients with CKD stages G4-G5 or on KRT. METHODS: In this national prospective observational cohort study we will follow patients with CKD stages G4-G5 or on KRT (n = 12,000) after SARS-CoV-2 vaccination according to the Dutch vaccination program. Blood will be drawn for antibody response measurements at day 28 and month 6 after completion of vaccination. Patient characteristics and outcomes will be extracted from registration data and questionnaires during 2 years of follow-up. Results will be compared with a control group of non-vaccinated patients. The level of antibody response to vaccination will be assessed in subgroups to predict protection against COVID-19 breakthrough infection. RESULTS: The primary endpoint is efficacy of SARS-CoV-2 vaccination determined as the incidence of COVID-19 after vaccination. Secondary endpoints are the antibody based immune response at 28 days after vaccination, the durability of this response at 6 months after vaccination, mortality and (serious) adverse events. CONCLUSION: This study will fulfil the lack of knowledge on efficacy and safety of SARS-CoV-2 vaccination in patients with CKD stages G4-G5 or on KRT. TRIAL REGISTRATION: The study protocol has been registered in clinicaltrials.gov ( NCT04841785 ). Current knowledge about this subject COVID-19 has devastating impact on patients with CKD stages G4-G5, on dialysis or after kidney transplantation. Effective SARS-CoV-2 vaccination is very important in these vulnerable patient groups. Recent studies on vaccination in these patient groups are small short-term studies with surrogate endpoints. Contribution of this study Assessment of incidence and course of COVID-19 after various types of SARS-CoV-2 vaccination during a two-year follow-up period in not only patients on dialysis or kidney transplant recipients, but also in patients with CKD stages G4-G5. Quantitative analysis of antibody response after SARS-CoV-2 vaccination and its relationship with incidence and course of COVID-19 in patients with CKD stages G4-G5, on dialysis or after kidney transplantation compared with a control group. Monitoring of (serious) adverse events and development of anti-HLA antibodies. Impact on practice or policy Publication of the study design contributes to harmonization of SARS-CoV-2 vaccine study methodology in kidney patients at high-risk for severe COVID-19. Data on efficacy of SARS-CoV-2 vaccination in patients with CKD will provide guidance for future vaccination policy.
| Original language | English |
|---|---|
| Article number | 55 |
| Pages (from-to) | 55 |
| Number of pages | 1 |
| Journal | BMC Nephrology |
| Volume | 23 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Dec 2022 |
Bibliographical note
Funding Information:The RECOVAC consortium received funding by The Netherlands Organisation for Health Research and Development (ZonMw) and the Dutch Kidney Foundation. Peer-review has been conducted by the ZonMW committee. The consortium is endorsed by the Dutch Federation of Nephrology (NFN), Dutch Transplant Society (NTV), Dutch Kidney Patient Association (NVN) and the Dutch Kidney Foundation (Nierstichting). The RECOVAC consortium will share data with the RIVM and Netherlands Pharmacovigilance Center (LAREB) whenever deemed relevant.
Funding Information:
We would like to thank the RECOVAC collaborators Marcia L Kho,1 Debbie van Baarle,2 Renate G van der Molen,3 Carla C Baan,4 Dimitri A Diavatopoulos,5 Ester BM Remmerswaal,6 Celine Imhof,7 Reshwan SRK Malahe,8 Sophie C Frölke,9 Nynke Rots,10 Fiona van der Klis,11 Ester ten Hoope,12 Wanda S Konijn,13 Tony de Ronde,14 Johanna PM Vervoort15 and Marion HJ Braks.16 1 Erasmus Medical Center, Internal Medicine, Nephrology and Transplantation, Erasmus MC Transplant Institute. Rotterdam, the Netherlands.2 University Medical Center Groningen, Medical Microbiology and Infection Prevention. Groningen, the Netherlands.3 Radboud Institute for Molecular Life Sciences, Dept. of Laboratory Medicine, Laboratory of Medical Immunology, Radboud University Medical Center. Nijmegen, The Netherlands.4 Erasmus Medical Center, Internal Medicine, Nephrology and Transplantation, Erasmus MC Transplant Institute. Rotterdam, the Netherlands.5 Radboud Institute for Molecular Life Sciences; Dept. of Laboratory Medicine, Laboratory of Medical Immunology, section Pediatric Infectious Diseases; Radboud Center for Infectious Diseases, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.6 Dept. of Experimental Immunology, Amsterdam Infection and Immunity Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.7 Dept. of Nephrology, University Medical Center Groningen, University of Groningen. Groningen, the Netherlands.8 Erasmus MC transplant institute, University Medical Center Rotterdam, Department of Internal Medicine Rotterdam, the Netherlands.9 Dept. of Internal Medicine, Div. of Nephrology. Amsterdam University Medical Center – Location Amsterdam Medical Center, Amsterdam, the Netherlands.10, 11 Center for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands.12–16 Dutch Kidney Patient Association (NVN), Bussum, the Netherlands.
Publisher Copyright:
© 2022, The Author(s).
