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• W4381051166 abstract "Infectious disease is the second leading cause of death among hemodialysis (HD) patients, and the standardized mortality ratio for all infectious diseases was 7.5 in hemodialysis (HD) patients compared to the general population in Japan in 2008–2009. 1Wakasugi M. Kawamura K. Yamamoto S. Kazama J.J. Narita I. High mortality rate of infectious diseases in dialysis patients: a comparison with the general population in Japan.Ther Apher Dial. 2012; 16: 226-231https://doi.org/10.1111/j.1744-9987.2012.01062.xCrossref PubMed Scopus (49) Google Scholar Uremia in end-stage renal diseases impairs humoral as well as cell-mediated immunity by depleting B cells and dendritic cells, which results in higher morbidity of infectious diseases and mortality in HD patients. 2Vaziri N.D. Pahl M.V. Crum A. Norris K. Effect of uremia on structure and function of immune system.J Ren Nutr. 2012; 22: 149-156https://doi.org/10.1053/j.jrn.2011.10.020Abstract Full Text Full Text PDF PubMed Scopus (245) Google Scholar Indeed, the mortality of coronavirus disease (COVID-19) in HD patients exceeded 20%.3Li P, Guan Y, Zhou S, et al. Mortality and risk factors for COVID-19 in hemodialysis patients: A systematic review and meta-analysis. Sci Prog. 2022;105(3):368504221110858. doi: 10.1177/00368504221110858.Google Scholar Therefore, it is important to elucidate whether the infection-preventive effect and reduction of severe disease in clinical trials of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines4olack 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: 2603-2615https://doi.org/10.1056/NEJMoa2034577Crossref Scopus (7939) Google Scholar apply to HD patients. Recently, several reports have been published on the humoral response of HD patients to the SARS-CoV-2 vaccine. However, almost all of these reports are based on spike protein-specific antibody assays, 5Grupper A. Sharon N. Finn T. et al.Humoral response to the Pfizer BNT162b2 vaccine in patients undergoing maintenance hemodialysis.Clin J Am Soc Nephrol. 2021; 16: 1037-1042https://doi.org/10.2215/CJN.03500321Crossref PubMed Scopus (214) Google Scholar,6Kanai D. Wakui H. Haze T. et al.Improved immune response to the third COVID-19 mRNA vaccine dose in hemodialysis patients.Kidney Int Rep. 2022; 7: 2718-2721https://doi.org/10.1016/j.ekir.2022.09.005Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar and only one study has used the virus neutralization test; 7Kohmer N. Rabenau H.F. Ciesek S. et al.Heterologous immunization with BNT162b2 followed by mRNA-1273 in dialysis patients: seroconversion and presence of neutralizing antibodies.Nephrol Dial Transplant. 2022; 37: 1132-1139https://doi.org/10.1093/ndt/gfac018Crossref Scopus (6) Google Scholar furthermore, none of the study results have been discussed based on comparison with healthy subjects using virus neutralization tests including Delta and Omicron variants. Therefore, we conducted this study to compare and evaluate the humoral response to the SARS-CoV-2 mRNA vaccine in HD patients with chronic renal failure with that in healthy controls using the plaque reduction neutralization test (PRNT), and to obtain an optimal cut-off value of spike protein-specific antibody titer for virus neutralization in HD patients. The backgrounds of the patients and controls who participated in this study are listed in Supplementary Table 1 and 2. The significant differences between the two groups, the HD patients and the healthy control, were observed in sex, age, and incidence of diabetes mellitus (DM). The results of the spike protein-specific antibody immunoassay test (Elecsys®) and PRNT are shown in Figures 1. A total of three HD patients had SARS-CoV-2 infection episodes confirmed by PCR test after the second vaccination. These three patients were excluded from analysis. Regarding anti-nucleocapsid protein antibodies measured at each point, no objective showed positive results except for known infection episodes. The spike antibody test was not performed in a HD patient at 6 weeks. The HD patient group had significantly lower spike protein-specific antibodies than the volunteer non-dialysis group at weeks 3, 6, 12, and 30. However, there was no significant difference between the two groups at weeks 33 (Figure 1A). PRNT results showed that the neutralizing activity against the Wuhan strain and Delta variant was significantly lower in HD patients at week 3. However, after week 12, there was no difference in the neutralizing activity between the two groups (Figure 1B). The early humoral response was lower in HD patients. Therefore, we categorized the HD patients into antibody-positive and antibody-negative groups according to the PRNT result at week 3 and compared the factors potentially related to the lower immune response in the two groups (Supplemental Table 3). However, significant associations were not observed between a lower humoral response and the previously reported factors5Grupper A. Sharon N. Finn T. et al.Humoral response to the Pfizer BNT162b2 vaccine in patients undergoing maintenance hemodialysis.Clin J Am Soc Nephrol. 2021; 16: 1037-1042https://doi.org/10.2215/CJN.03500321Crossref PubMed Scopus (214) Google Scholar,6Kanai D. Wakui H. Haze T. et al.Improved immune response to the third COVID-19 mRNA vaccine dose in hemodialysis patients.Kidney Int Rep. 2022; 7: 2718-2721https://doi.org/10.1016/j.ekir.2022.09.005Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar in the present study. The correlations between spike protein-specific antibody titers assessed by the immunoassay and PRNT titers for all three COVID-19 variants were evaluated in the volunteer group and HD group (Supplementary Figure 1). These correlations were very high in both the control and HD patient groups but slightly lower for the Delta and Omicron variants. Accuracy of spike protein-specific antibody (Elecsys®) for positive neutralizing activity against each viral strain The predictive accuracy of the spike protein-specific antibody assessed by immunoassay (Elecsys®) for neutralizing activity (PRNT50 ≥10) against each SARS-CoV-2 strain was evaluated in both groups using receiver operating curves (ROC) (Figure 2). The optimal cut-off values calculated by the Youden index were as follows: in the volunteer group, 148 U/mL (sensitivity: 86.8%, specificity: 96%) against the Wuhan strain; 457 U/mL (sensitivity: 75.4%, specificity: 66.3%) against the Delta variant; 5410 U/mL (sensitivity: 100%, specificity: 100%) against the Omicron BA.1 variant; HD group, 28.8 U/mL against the Wuhan strain (sensitivity: 89.2%, specificity: 96.6%); 388 U/mL against the Delta variant (sensitivity: 84.9%, specificity: 94.7%); and 3300 U/mL for the Omicron BA.1 variant (sensitivity: 95.7%, specificity: 99.2%). The cut-off values in HD group were approximately 10 times higher for the Delta variant than for the Wuhan strain, and even 10 times higher for the Omicron variant BA.1. As for the differences in the accuracy between the control and HD patients, they were not obvious in our samples of the Wuhan and the Omicron BA. 1 strains (the AUCs in the control/ HD patients were 0.9621/ 0.9541 and 1.0000/ 0.9956, respectively). On the other hand, the difference was not trivial in the Delta variant (the AUCs in the control/ HD patients were 0.6930/ 0.9295). The present study showed that the humoral response after the first dose of the SARS-CoV-2 mRNA vaccine was significantly reduced in HD patients than in the control group. However, the neutralizing activities were similar between the HD and control groups 9 weeks after the second vaccination, and before/after the third vaccination. Commercial spike protein-specific antibody titers were significantly higher in the healthy volunteers up to 9 weeks after the second vaccination, although the difference was small, as previously reported. 5Grupper A. Sharon N. Finn T. et al.Humoral response to the Pfizer BNT162b2 vaccine in patients undergoing maintenance hemodialysis.Clin J Am Soc Nephrol. 2021; 16: 1037-1042https://doi.org/10.2215/CJN.03500321Crossref PubMed Scopus (214) Google Scholar,6Kanai D. Wakui H. Haze T. et al.Improved immune response to the third COVID-19 mRNA vaccine dose in hemodialysis patients.Kidney Int Rep. 2022; 7: 2718-2721https://doi.org/10.1016/j.ekir.2022.09.005Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar This trend was similar to that observed in patients with autoimmune diseases taking immunosuppressive drugs such as steroids and JAK inhibitors, except for tumor necrosis factor-α inhibitors and CD20 antibodies. 8Jena A, Mishra S, Deepak P, et al. Response to SARS-CoV-2 vaccination in immune mediated inflammatory diseases: systematic review and meta-analysis. Autoimmun Rev. 2022;21(1):102927. doi: 10.1016/j.autrev.2021.102927.Google Scholar,9Benucci M. Damiani A. Gobbi F.L. et al.Role of booster with BNT162b2 mRNA in SARS-CoV-2 vaccination in patients with rheumatoid arthritis.Immunol Res. 2022; 70: 493-500https://doi.org/10.1007/s12026-022-09283-yCrossref Scopus (8) Google Scholar Furthermore, a very high correlation was observed between spike protein-specific antibody titers and neutralizing antibody titers against the Wuhan strain in both control and dialysis patient groups as the spike-specific antibody was developed for the wild-type Wuhan strain. These correlations were very high in both the control and HD patient groups but slightly lower for the Delta and Omicron variants. The prediction accuracy of the spike protein-specific antibodies (Elecsys®) for neutralizing activity (PRNT50≥10) against each SARS-CoV-2 strain was very high, with an AUC of 0.9 or higher, except for the Delta variant in the volunteer group. It was not clear why the correlation for the Delta variant in the volunteer group was relative lower than other groups. We also analyzed the correlation between PRNT and commercially available spike protein-specific antibody kit results. Thus, we set optimal cut-off values for each SARS-CoV-2 strain and compared the cut-off values of HD with those of the control group. The cut-off values in the HD and control groups were similar for each viral strain; the cut-off value of 28.8 U/mL for the Wuhan strain in the HD group was lower than the previously reported value of 196 U/mL. 7Kohmer N. Rabenau H.F. Ciesek S. et al.Heterologous immunization with BNT162b2 followed by mRNA-1273 in dialysis patients: seroconversion and presence of neutralizing antibodies.Nephrol Dial Transplant. 2022; 37: 1132-1139https://doi.org/10.1093/ndt/gfac018Crossref Scopus (6) Google Scholar The limitations of our study are as follows: first, the number of participants was relatively small so, the predictive accuracy and the cut-off values can vary in other samples; second, the HD patients were significantly older than control, although the ages of the two groups were not as far apart as in previous reports, 5Grupper A. Sharon N. Finn T. et al.Humoral response to the Pfizer BNT162b2 vaccine in patients undergoing maintenance hemodialysis.Clin J Am Soc Nephrol. 2021; 16: 1037-1042https://doi.org/10.2215/CJN.03500321Crossref PubMed Scopus (214) Google Scholar,6Kanai D. Wakui H. Haze T. et al.Improved immune response to the third COVID-19 mRNA vaccine dose in hemodialysis patients.Kidney Int Rep. 2022; 7: 2718-2721https://doi.org/10.1016/j.ekir.2022.09.005Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar third, cellular immunity was not evaluated. The strengths of this study are that almost none of the HD patients were taking steroids or immunosuppressive drugs, and were unaffected by these medications. In addition, we evaluated the neutralizing activity of antibodies in HD patients over time using several strains of live SARS CoV-2 viruses and were able to correlate the results with spike protein-specific antibody titers determined using commercially available kits and calculate optimal cut-off values for each virus strain. In conclusion, the initial humoral response after SARS-CoV-2 mRNA vaccination was lower in HD patients than in the controls. This indicates that the booster vaccination is indispensable in HD patients. Therefore, in a future pandemic caused by a new virus or the emergence of a new variant with extremely reduced efficacy of existing vaccines, HD patients will likely require multiple doses of a new vaccine. Continued evaluation of the response to future Omicron-compatible vaccines and the neutralizing antibody activity against new mutant strains is also needed. This research was supported by a grant from the Public Foundation of the Vaccination Research Center of Japan. Download .pdf (.34 MB) Help with pdf files" @default.
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• W4381051166 title "Long-term neutralizing antibody titers after BNT162b2 vaccination in hemodialysis patients" @default.
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