Vaccine Response in Severe CKD

In patients with chronic kidney disease (CKD) stages G4-G5,or receiving kidney replacement therapy (KRT: dialysis, or kidney transplantation), there are associations between COVID-19 and increased morbidity and mortality. Trials of SARS-CoV-2 vaccine do not commonly include that patient population. It is known that vaccination against other viruses is less effective in kidney patients.

P.Bouwmans, PhD, and colleagues described a national prospective observational study examine the safety and efficacy of various types of SARS-CoV-2 vaccines in patients with CKD stages G4-G5 or on KRT. Results were reported online in BMC Nephrology [doi:10.1186/s12882-022-02680-3].

The study cohort will include 12,000 patients with CKD stages G4-G5 or on KRT following SARS-CoV-2 vaccination according to the Dutch vaccination program. Blood will be drawn for measurement of antibody response at day 28 and month 6 following completion of vaccination. Registration data and questionnaires during 2 years of follow-up will be used to determine patient characteristics and outcomes. Results will be compared with a control group of non-vaccinated patients. To predict protection against COVID-19 breakthrough infection, the level of antibody response to vaccination will be assessed in subgroups.

The primary end point of interest is the efficacy of SARS-CoV-2 vaccination, determined as the incidence of COVID-19 after vaccination. Secondary end points are the antibody based immune response at 28 days after vaccination, the durability of the response at 6 months after vaccination, mortality, and (serious) adverse events.

The researchers said, “This study will fulfill the lack of knowledge on efficacy and safety of SARS-CoV-2 vaccination in patients with CKD stages G4-G5 or on KRT.”