BackgroundHemodialysis patients are at high risk for severe COVID-19. SARS-CoV-2 vaccination related safety and immunogenicity data in these patients are rare.MethodsIn this observational study SARS-CoV-2-seronegative hemodialysis patients were vaccinated with two doses of the Pfizer/BioNTech mRNA-BNT162b2 vaccine (COMIRNATY® 30 µg) and followed for 90 days. Local and systemic side effects were assessed at every dialysis session during the first post-vaccination week after the first and second vaccine dose. Immunogenicity was determined four weeks after vaccination by quantifying anti-SARS-CoV-2 spike protein IgG antibodies (LIAISON® SARS-CoV-2-TrimericS IgG chemiluminescent immunoassay) expressed in binding activity units per milliliter (BAU/mL) adapted to the WHO International standard.ResultsFifty patients (32% women, 68% men) with a mean (SD) age of 67.6 (14.8) years were included. Mild local reactions occurred in 38% after the first injection, and in 29.2% with mild, in 2.1% with moderate and in 2.1% with severe degree after the second injection. Systemic reactive events occurred less often, with diarrhea (4% mild, 4% moderate) and fatigue (8% mild) being the most frequent ones. After the first injection 42% of the patients developed a positive response using the assay specific cut-off value of 33.8 binding activity units per milliliter (BAU/mL) with a median (Q1, Q3) anti-SARS-CoV-2 spike IgG concentration of 20.0 (11.7, 51.0) BAU/mL. After the second injection the percentage of seropositive patients increased to 97.9% with an anti-SARS-CoV-2 spike IgG concentration of 1075 (290.8, 1735) BAU/mL. Higher age and immunosuppression were associated with lower, calcitriol treatment and prior seroconversion to hepatitis B vaccination with significantly higher antibody concentration.ConclusionsThe mRNA-BNT162b2 SARS-CoV-2 vaccine appears to be safe and well-tolerated and shows a high immunogenicity in hemodialysis patients.

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Vaccination against SARS-CoV-2 is the most important advance in the fight against the ongoing coronavirus pandemic. Recent case reports show that the SARS-CoV-2 vaccines can very rarely cause de novo or relapsing glomerular disease. Here, we report two female patients with microscopic polyangiitis, who developed severe glomerulonephritis after immunisation with the BNT162b2 mRNA vaccine. One patient with a possible ongoing but undiagnosed disease developed severe necrotising glomerulonephritis after the second vaccination. In the other patient with a long-lasting disease, rituximab maintenance therapy had been postponed because of the coronavirus pandemic. She noted macrohematuria immediately after the second vaccine dose and developed a severe renal relapse leading to end-stage kidney disease. We suggest that patients with ANCA-associated vasculitis be carefully monitored for disease activity immediately before and after receiving the SARS-CoV-2 vaccination, especially if maintenance therapy has been interrupted. Ultimately, mRNA vaccines should probably be avoided in these patients.

BackgroundDue to the waning humoral response after a two-dose SARS-CoV-2 mRNA vaccination, a third booster was recommended in hemodialyis patients. Data on a heterologous mRNA-vector regimen, which might improve immunogenicity, are very limited.MethodsIn this observational study 36 chronic hemodialysis patients (mean (SD) age 66.9 (15.9) years, 33.3% females) were followed up for 13 months. All patients were vaccinated twice using the mRNA-BNT162b2 vaccine, followed by a 3rd dose of the vector vaccine Ad26COVS1 eight months later. We assessed the humoral response by quantifying the anti-SARS-CoV-2 spike IgG antibody and neutralizing antibody concentrations. The cellular immune response was evaluated via SARS-CoV-2 spike protein-specific interferon-γ release assay.ResultsThe seroconversion rate was 47.2%, 100%, 69.4% and 100% one month after the 1st dose, one and six months after the 2nd dose and four months after the heterologous 3rd dose. The median (Q1, Q3) anti-SARS-CoV-2 spike IgG concentrations at the same time were 28.7 (13.2, 69.4) BAU/ml, 1130.0 (594.5, 1735.0) BAU/ml, 89.7 (26.4, 203.8) BAU/ml, and 2080.0 (1062.5, 2080.0) BAU/ml. The percentage of patients with neutralizing antibodies was 58.3% after the 2nd dose and improved to 100% after the 3rd dose (P <0.001). A positive T-cell response was found in 50% of patients after the 3rd dose.ConclusionsA third heterologous booster dose helped to sustain humoral immunity in almost all hemodialysis patients and induced a significant T-cellular response in half of them. Stimulating the immune response against SARS-CoV-2 by two different vaccine platforms seems to be a promising approach.

BackgroundThe ongoing SARS-CoV-2 pandemic forced many countries to implement strict and unprecedented precautions to stop the spread of the virus. On top of these measures, hemodialysis units have adopted their own rules to protect wards and patients from infection with SARS-CoV-2. Despite the rapidly growing knowledge on epidemiology, virology, and clinical disease, little is known about how these measures are perceived by patients themselves on hemodialysis.MethodsThe study was performed in the three hemodialysis units in Vorarlberg, Austria’s westernmost state. A questionnaire was developed consisting of 22 questions on patients’ perceptions of the COVID-19 crisis and their feelings about the general precautions and specific steps implemented on dialysis wards. All adult patients were asked to fill out the questionnaire anonymously.ResultsOf 202 patients on hemodialysis, 148 completed the questionnaire (66.9% men, mean age 68.3±13.3 years). The vast majority (83.1%) were worried by the COVID-19 crisis, but only 28.4% reported a negative effect on emotional well-being. Daily life was most affected by the general ban on visitors (58.6%) and home confinement (35.9%). Of the patients, 64.2% feared contracting COVID-19, 30.7% were afraid of financial consequences, and 14.6% were afraid of loneliness and isolation. The safety measures on dialysis wards were classified as adequate by 97.3% of the respondents. Of the patients, 78.2% felt safe during dialysis treatment. All dialysis-specific precautions (individual patient transport, health check, hand disinfection, wearing a face mask, and physical distancing) were rated important or very important by almost all patients. To date, none of the patients have acquired SARS-CoV-2 infection.ConclusionsAlthough the SARS-CoV-2 crisis brought worry to and affected the lives of most patients on hemodialysis, its effect on their emotional well-being was moderate. Patients felt safe on dialysis wards, and acceptance of specific precautions was high.

Solid organ transplant patients are at high risk for severe or fatal COVID-19 (1), even after two vaccinations (2). Recent studies show, that after a double vaccination course, the antibody response rate is as low as 48% (3). However, to our knowledge there is no data on differences in the natural or vaccineinduced SARS-CoV-2 humoral immunity evaluated in one and the same cohort of kidney transplant recipients (KTR). Here, we are reporting on and comparing the humoral response in 164 KTR (mean age 59.1 years (range 21-85 years), 61.6% male). The group included 142 patients who were vaccinated twice (72% Moderna mRNA-1273 vaccine; 27% Pfizer/BioNTech mRNA-BNT162b2 SARS-CoV-2 vaccine, 1% Oxford-AstraZeneca ChAdOx1-COVID-19 vaccine) and 22 patients after symptomatic and PCRconfirmed Covid-19. We assessed the humoral response on average (25th percentile, 75th percentile) 50 days (33.8, 62.0) after the second vaccine dose or 90 days (39.8, 143.0) after infection by quantifying anti-SARS-CoV-2 spike IgG antibodies. Most patients were treated with tacrolimus (74%), mycophenolic acid (71%) and prednisolone (57%). Eight percent were treated with belatacept. Convalescent KTR were significantly younger (p 0.009), had lower eGFR (p 0.021) and were more often treated with prednisolone (p 0.042) as shown in Table 1. Seroconversion was defined as an anti-SARS-CoV-2 IgG antibody concentration above the respective cut-off value according to the manufacturer of the assay. Details about the assays in use and their cut-off values are given in the Supplementary Material.The seroconversion rate in convalescent patients was 90.9 and 48.6% in vaccinated patients (p < 0.001). In the patients treated with belatacept, only one out of 12 (8.3%) vaccinated individuals had a seroconversion, whereas both naturally infected patients showed a response. In a multivariable logistic regression analysis infection compared to vaccination [odds ratio (OR) 18.98; 95% CI: 3.41, 105.58] and transplantation vintage (OR 1.01; 95% CI: 1.01, 1.02) were associated with a significantly higher likelihood of seroconversion. On the other hand, older age (OR 0.95; 95% CI: 0.93, 0.99) and belatacept treatment (OR 0.13; 95% CI: 0.02, 0.68) significantly decreased the likelihood of seroconversion. All model coefficients and odds can be found in the Supplementary Table S1.Like our results in convalescent KTR, Magicova et al. recently found a preserved humoral response after SARS-CoV-2 infection comparable to immunocompetent persons in a large Czech cohort of 1,037 kidney transplant recipients with a seroprevalence of 6.8% during the second infection wave in fall 2020 (4). In line with our findings, recent data in dialysis patients also show a superior humoral immune response in convalescent compared to vaccinated patients (5). Natural infection seems to be a stronger and quantitatively higher antigenic challenge than vaccination. In contrast to intramuscular vaccination, natural infection stimulates the resident immune system of mucous membranes, especially designed to