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      No Improvement of Hepatitis B Vaccination Response in Patients Dialysed with a Polymethylmethacrylate Membrane Compared to High-Flux Polysulfone: Results of the HEPADIAL Study

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          Background: An altered immune response and decreased vaccine response are observed in patients with chronic renal failure. A preliminary study of 15 non-immunised patients, despite appropriate previous hepatitis B vaccination, showed a 60% seroconversion rate after 3 months of dialysis with a polymethylmethacrylate (PMMA) membrane. This response was associated with circulating soluble CD40 (CD40s) decrease, a natural inhibitor of the humoral immune response. The aim of the study is to confirm these results in a randomised study. Methods: We conducted a multicentre randomised intention-to-treat superiority clinical trial comparing polysulfone and a PMMA membrane in 2 parallel patient groups. The primary end point was the vaccine response rate, as defined by an anti-HBs antibodies titre of >10 IU/L, 1 month after the last vaccination with a double dose of Engerix B20®, performed at weeks 12, 16, 20, and 36. Results: Twenty-five patients were randomised and included in an intention-to-treat analysis. They were dialysed on polysulfone ( n = 11) or PMMA ( n = 14) for 40 weeks. Fifty percent of the PMMA patients versus 54.5% of the polysulfone patients achieved seroconversion ( p = 1.00). The median anti-HBs antibody titre in responders at week 40 was 496 (92–750) versus 395 (43–572) UI/mL for PMMA and polysulfone, respectively ( p = 0.46). The median CD40s titre at week 12 was 306 (193–448) versus 491 (281–515) pg/mL ( p = 0.21). The CD40s median variation between week 0 and week 12 was 5 (–105 to 90) versus 64 (–63 to 123) pg/mL ( p = 0.55). The CD40s level at week 12 in non-responders was slightly inferior to that of the responders: median 193 (168–331) versus 413 (281–512) pg/mL ( p = 0.08). Conclusion: We did not observe a better vaccine response with the PMMA membrane compared to high-flux polysulfone. The PMMA membrane did not decrease the CD40s more than the polysulfone membrane probably because the titre was previously low in the 2 groups.

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          Author and article information

          Blood Purif
          Blood Purification
          S. Karger AG
          May 2020
          13 November 2019
          : 49
          : 3
          : 265-271
          aDepartment of Nephrology-Transplantation-Dialysis-Apheresis, Bordeaux University Hospital, Bordeaux, France
          bClinical Epidemiology Unit, Bordeaux University Hospital, Bordeaux, France
          cDepartment of Nephrology-Haemodialysis, Hospital of the Basque Coast, Bayonne, France
          dAURAD Aquitaine, Gradignan, France
          eDepartment of Nephrology-Dialysis, Hospital of North Ardèche, Annonay, France
          fDepartment of Nephrology and Organ Transplantation, Toulouse University Hospital, Toulouse, France
          gCTMR, Bordeaux, France
          hDepartment of Nephrology, Besançon University Hospital, Besançon, France
          iDepartment of Immunology and Immunogenetics, Bordeaux University Hospital, Bordeaux, France
          jCNRS-UMR5164 ImmunoConcEpT, Bordeaux University Hospital, Bordeaux, France
          Author notes
          *Valérie de Précigout, Service de Néphrologie-Transplantation-Dialyse-Aphérèses, Hôspital Pellegrin, Place Amélie Raba Léon, FR–33076 Bordeaux cedex (France), E-Mail valerie.deprecigout@chu-bordeaux.fr
          504035 Blood Purif 2020;49:265–271
          © 2019 S. Karger AG, Basel

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          Page count
          Figures: 4, Tables: 2, Pages: 7
          Research Article

          Cardiovascular Medicine, Nephrology

          Soluble CD40, Polymethylmethacrylate, Hepatitis B


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