Abstract

Patients with kidney failure have notoriously weak responses to common vaccines. Thus, immunogenicity of novel SARS-CoV-2 vaccines might be impaired in this group. To determine immunogenicity of SARS-CoV-2 vaccination in patients with chronic dialysis, we analyzed the humoral and T-cell response after two doses of mRNA vaccine Tozinameran (BNT162b2 BioNTech/Pfizer). This observational study included 43 patients on dialysis before vaccination with two doses of Tozinameran 21 days apart. Overall, 36 patients completed the observation period until three weeks after the second dose and 32 patients were further analyzed at week 10. Serum samples were analyzed by SARS-CoV-2 specific IgG and IgA antibodies ~1, ~3–4 and ~10 weeks after the second vaccination. In addition, SARS-CoV-2-specific T-cell responses were assessed at ~3–4 weeks by an interferon-gamma release assay (IGRA). Antibody and T cell outcomes at this timepoint were compared to a group of 44 elderly patients not on dialysis, after immunization with Tozinameran. Median age of patients on chronic dialysis was 74.0 years (IQR 66.0, 82.0). The proportion of males was higher (69.4%) than females. Only 20/36 patients (55.6%, 95%CI: 38.29–71.67) developed SARS-CoV-2-IgG antibodies at the first sampling, whereas 32/36 patients (88.9%, 95%CI: 73.00–96.38) demonstrated IgG detection at the second sampling. In a longitudinal follow-up at ~10 weeks after the second dose, the proportion of dialysis patients reactive for anti-SARS-CoV-2-IgG decreased to 27/32 (84.37%, 95%CI: 66.46–94.10) The proportion of anti-SARS-CoV-2 S1 IgA decreased from 33/36 (91.67%; 95%CI: 76.41–97.82) at weeks 3–4 down to 19/32 (59.38; 95%CI: 40.79–75.78). Compared to a cohort of vaccinees with similar age but not on chronic dialysis seroconversion rates and antibody titers were significantly lower. SARS-CoV-2-specific T-cell responses 3 weeks after second vaccination were detected in 21/31 vaccinated dialysis patients (67.7%, 95%CI: 48.53–82.68) compared to 42/44 (93.3%, 95%CI: 76.49–98.84) in controls of similar age. Patients on dialysis demonstrate a delayed, but robust immune response three to four weeks after the second dose, which indicates effective vaccination of this vulnerable group. However, the lower immunogenicity of Tozinameran in these patients needs further attention to develop potential countermeasures such as an additional booster vaccination.

Highlights

  • The coronavirus disease 2019 (COVID-19) pandemic has led to an urgent need for effective strategies, in particular for patients with kidney failure (KF), who have a high mortality [1]

  • 43 patients with chronic kidney disease (CKD) stage 5 were initially vaccinated with Tozinameran (BNT162b2 BioNTech/Pfizer)

  • Three out of 43 patients developed SARS-CoV-2 infection at 11, 14 and 16 days after the first vaccination, of whom one patient died from COVID-19 infection 19 days after the first vaccination

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Summary

Introduction

The coronavirus disease 2019 (COVID-19) pandemic has led to an urgent need for effective strategies, in particular for patients with kidney failure (KF), who have a high mortality [1]. The COVID-19 vaccine Tozinameran (BioNTech/Pfizer) showed protection from 12 days after the first dose [2] and was demonstrated to be 95% effective in preventing COVID-19 [3]. Robust SARS-CoV-2 antibody responses ≥7 days after the second dose were detected [4]. Patients with KF have an impaired response to vaccination [5] and the earliest reports on COVID-19 vaccination suggest that mRNA vaccines are immunogenic but some patients on dialysis do not seroconvert [6,7,8]. We investigated immunogenicity to COVID-19 vaccination with Tozinameran in 43 patients with chronic kidney disease (CKD) stage 5 and provide a longitudinal follow-up at 10 weeks after a second dose

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