Experience with SARS-CoV-2 BNT162b2 mRNA vaccine in dialysis patients
2021; Elsevier BV; Volume: 99; Issue: 6 Linguagem: Inglês
10.1016/j.kint.2021.04.006
ISSN1523-1755
AutoresNoa Berar Yanay, Sarit Freiman, Maanit Shapira, Samar Wishahi, Munir Hamze, Mohamad Elhaj, Maha Zaher, Zaher Armaly,
Tópico(s)SARS-CoV-2 detection and testing
ResumoThe immune system is profoundly affected by uremia. Patients with end-stage kidney disease (ESKD) may be more vulnerable to infections and may have suboptimal response to vaccination.1Reddy S. Chituri C. Yee J. Vaccination in chronic kidney disease.Adv Chronic Kidney Dis. 2019; 26: 72-78Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar Patients with ESKD and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease 2019 [COVID-19]) are at increased risk of infection and mortality.2Ng J.H. Hirsch J.S. Wanchoo R. et al.Outcomes of patients with end-stage kidney disease hospitalized with COVID-19.Kidney Int. 2020; 98: 1530-1539Abstract Full Text Full Text PDF PubMed Scopus (198) Google Scholar, 3Hilbrand L.B. Duivenvoorden R. Vart P. et al.COVID-19 related mortality in kidney transplant and dialysis patients: results of the ERACODA collaboration.Nephrol Dial Transplant. 2020; 35: 1973-1983Crossref PubMed Scopus (301) Google Scholar, 4Hsu C.M. Weiner D.E. Aweh G. et al.COVID-19 among US dialysis patients: risk factors and outcomes from national dialysis provider.Am J Kidney Dis. 2021; 77: 748-756Abstract Full Text Full Text PDF PubMed Scopus (159) Google Scholar The first emergency-use authorizations for COVID-19 vaccines were granted by the Food and Drug Administration in December 2020, and clinical trials for the approval of more vaccines are ongoing. However, the representation of patients with chronic kidney disease and ESKD in these trials is low or unreported.5Glenn D.A. Hedge A. Kotzen E. et al.Systematic review of safety and efficacy of COVID-19 vaccines in patients with kidney disease [e-pub ahead of print]. Kidney Int Rep.https://doi.org/10.1016/j.ekir.2021.02.01Google Scholar The Pfizer BiONTech trial of the BNT162b2 vaccine included 256 patients with renal disease with no further details on the stages of the chronic kidney disease.6Polack F.P. Thomas S.J. Kitchin N. et al.Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine.N Engl J Med. 2020; 383: 2603-2615Crossref PubMed Scopus (9627) Google Scholar We investigated dialysis patients and a control group who had completed 2 doses of vaccination with the mRNA BNT162b2 vaccine for anti–spike protein antibody response (LIAISON SARS-CoV-2 S1/S2 IgG; DiaSorin) and observed them for up to 10 weeks (for detailed methods, see the Supplementary Methods). A total of 160 chronic dialysis patients (127 hemodialysis and 33 peritoneal dialysis patients) and 132 control group persons were analyzed (Table 1). The median age of the dialysis group was 69 years (interquartile range [IQR], 62–78 years), and of the control group, 50.5 years (IQR, 41–60 years; P < 0.001). A total of 63% in the dialysis group and 51% in the control group were men (P = 0.022). In the dialysis group, 79% were on hemodialysis and 21% were on peritoneal dialysis. The median dialysis vintage was 3.2 years (IQR, 1.6–5.4 years).Table 1Participants and response to BNT162b2 mRNA vaccineVariableDialysis patients (n = 160)Control group (n = 132)P valueAge, median [IQR], yr69 [62–78]50.5 [41–60]<0.001Male101 (63)67 (51)0.022Female59 (37)65 (49)Hemodialysis127 (79)——Peritoneal dialysis33 (21)——Dialysis vintage, median [IQR], yr3.21 [1.60–5.39]——Anti–spike antibody negative (<15 AU/ml)16 (10)0<0.001Anti–spike antibody level, median [IQR], AU/ml116.5 [66.0–160.0]176.5 [142–235]<0.001COVID-19 infection after complete vaccination6 (3.75)00.033AU, arbitrary unit; COVID-19, coronavirus disease 2019; IQR, interquartile range.Data are given as n (%), unless otherwise indicated. Open table in a new tab AU, arbitrary unit; COVID-19, coronavirus disease 2019; IQR, interquartile range. Data are given as n (%), unless otherwise indicated. A total of 90% of the dialysis group and 100% of the control group were positive for anti–spike antibodies (P < 0.0001). The median level of anti–spike antibody was 116.5 arbitrary unit (AU)/ml (IQR, 66–160 AU/ml) in the dialysis group and 176.5 AU/ml (IQR, 142–235 AU/ml) in the control group (P < 0.001). In the dialysis group, in patients aged ≥75 years, the median anti–spike antibody level was 99.5 AU/ml (IQR, 28.75–139.5 AU/ml), and in patients aged <75 years, the median level was 122 AU/ml (IQR, 72.8–167.0 AU/ml; P = 0.035) (Supplementary Figure S1). In the dialysis group, we compared the lowest anti–spike antibody level quartile group (antibody level, 400 AU/ml); the median age in the lowest quartile was 72 years (IQR, 66.25–81.00 years), and in the highest quartile, 67 years (IQR, 56.25–74.00 years; P = 0.02). These 2 subgroups did not differ in dialysis modality, dialysis vintage, and sex distribution (Supplementary Table S1). Six hemodialysis patients (3.75%) and none in the control group developed a new COVID-19 infection (confirmed by positive COVID-19 reverse transcriptase–polymerase chain reaction) >7 days after completion of the recommended vaccination regimen (P = 0.033). Epidemiological investigation indicated that the infection was acquired from family members in 2 patients, at the dialysis facility in the other 2 patients, in a religious gathering in another patient, and from an unknown source for 1 patient. The virus variant was determined in 2 patients, and the B.1.1.7 – UK (L5F[S]) variant was confirmed. All 6 patients had symptoms compatible with COVID-19 infection. The clinical course was severe for 1 patient, moderate for 3 patients, and mild for 2 patients. All of them recovered (Supplementary Table S2). Of these 6 patients, 4 had an anti–spike antibody level in the lowest quartile ( 7 days after completion of the 2-dose vaccination. This rate is higher than that reported (0.043%) of new infection in the phase 3 clinical trial of BNT162b26Polack F.P. Thomas S.J. Kitchin N. et al.Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine.N Engl J Med. 2020; 383: 2603-2615Crossref PubMed Scopus (9627) Google Scholar and is also higher than 0 events in our control group. It is possible that evolving SARS-CoV-2 variants may be associated with different rates of protection of the vaccine, but the participants in both of our groups live in the same area and were vaccinated and investigated at the same time. Therefore, different virus variants are less likely to contribute to the between-group difference. The anti–spike antibody levels in patients who developed COVID-19 infection after vaccination were in the lowest quartile. The assumption of a correlation between antibody levels and protection from future COVID-19 infection should be further investigated. Some important issues remain unanswered: What is the immunogenicity pattern for other vaccines? Should we routinely determine antibody response in dialysis patients following vaccination against COVID-19? Should we give a booster dose(s) when the antibody level is low? Considering the results of our study, and although many limitations related to COVID-19 are expected to ease in the near future, we may consider maintaining physical distancing and other recommended measures in place for protection of the dialysis population. Our findings are limited by a relatively small number of participants and a short-term follow-up. Download .docx (.05 MB) Help with docx files Supplementary File (PDF) Outcomes of patients with end-stage kidney disease hospitalized with COVID-19Kidney InternationalVol. 98Issue 6PreviewGiven the high risk of infection-related mortality, patients with end-stage kidney disease (ESKD) may be at increased risk with COVID-19. To assess this, we compared outcomes of patients with and without ESKD, hospitalized with COVID-19. This was a retrospective study of patients admitted with COVID-19 from 13 New York hospitals from March 1, 2020, to April 27, 2020, and followed through May 27, 2020. We measured primary outcome (in-hospital death), and secondary outcomes (mechanical ventilation and length of stay). Full-Text PDF Immune response to SARS-CoV-2 infection and vaccination in patients receiving kidney replacement therapyKidney InternationalVol. 99Issue 6PreviewIn this issue of Kidney International, the initial experience regarding the immunogenicity of prior coronavirus disease 2019 (COVID-19) infection and the response to the COVID-19 vaccines among patients on maintenance dialysis and kidney transplant recipients is summarized. Preliminary data suggest that there is durability of immune response after COVID-19 infection. Although immune response to the first dose of vaccine is less in infection-naïve patients than healthy individuals in both groups, after the second vaccine dose a significant portion of patients receiving maintenance dialysis develop robust antibody titers, whereas kidney transplant recipients show a less-strong immune response. Full-Text PDF Neutralizing antibody response against variants of concern after vaccination of dialysis patients with BNT162b2Kidney InternationalVol. 100Issue 3PreviewWe and others showed high seroconversion rates after BNT162b2 mRNA vaccination in patients on hemodialysis, but still significantly lower rates as compared to those of healthy controls.1–3 Variants of concern (VOCs) such as B.1.351 (beta variant) or B.1.617.2 (delta variant) partially escape from neutralizing antibodies (NAbs) and will probably replace wild-type severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or the B.1.1.7 (alpha) variant with increasing immunity in the population, induced by natural infection or vaccination. Full-Text PDF Anti–SARS-CoV-2 spike protein S1 receptor-binding domain antibody after vaccination with inactivated whole-virus SARS-CoV-2 in end-stage kidney disease patients: an initial reportKidney InternationalVol. 100Issue 5PreviewPatients with end-stage kidney disease (ESKD) are at greater risk for morbidity and mortality following coronavirus disease 2019 (COVID-19) than the general population.1 Vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for this vulnerable population is the main priority to prevent COVID-19 and mitigate unfavorable or severe complications. However, the immune responses to vaccination in patients with ESKD may be altered by accumulation of uremic toxins and comorbidities. Full-Text PDF Humoral response of the mRNA-1273 SARS-CoV-2 vaccine in peritoneal dialysis patientsKidney InternationalVol. 100Issue 2PreviewPatients with end-stage kidney disease on peritoneal dialysis are known to have an altered cellular and humoral immunity evidenced by the reduced response they have to several vaccines, such as the hepatitis B or influenza vaccine, albeit their response rate is slightly higher than that of patients on hemodialysis.1 Full-Text PDF
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