Long-term efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease, on dialysis or after kidney transplantation: a national prospective observational cohort study

BMC Nephrology

RECOVAC Collaborators¹  T. Rispens²  M. Steenhuis²  M. A. Ten Dam³  F. J. Bemelman⁴  M. H. Hemmelder⁵  P. Bouwmans⁵  P. Vart⁶  A. P. J. de Vries⁷  A. C. Abrahams⁸  M. A. van den Dorpel⁹  L. Hilbrands^1,10  J. S. Sanders^1,11  R. T. Gansevoort^1,11  A. L. Messchendorp^1,11  M. E. J. Reinders^1,12 

[1] ;Department of Immunopathology, Sanquin Research;Department of Internal Medicine, Canisius Wilhelmina Hospital;Department of Internal Medicine, Division of Nephrology, Amsterdam University Medical Center – location Amsterdam Medical Center;Department of Internal Medicine, Division of Nephrology, Maastricht University Medical Center;Department of Internal Medicine, University Medical Center Groningen;Department of Medicine, Division of Nephrology, and Leiden Transplant Center, Leiden University Medical Center;Department of Nephrology and Hypertension, University Medical Center Utrecht;Department of Nephrology, Maasstad Hospital;Department of Nephrology, Radboud University Medical Center;Department of Nephrology, University Medical Center Groningen, University of Groningen;Internal Medicine, Nephrology and Transplantation, Erasmus MC Transplant Institute, Erasmus Medical Center;

关键词: SARS-CoV-2;    Vaccine;    Chronic kidney disease;    Kidney transplantation;    Dialysis;    Safety;   

DOI  :  10.1186/s12882-022-02680-3

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown