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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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          Abstract

          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

          Journal
          BPU
          Blood Purif
          10.1159/issn.0253-5068
          Blood Purification
          S. Karger AG
          0253-5068
          1421-9735
          2020
          May 2020
          13 November 2019
          : 49
          : 3
          : 265-271
          Affiliations
          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
          Article
          504035 Blood Purif 2020;49:265–271
          10.1159/000504035
          31722332
          © 2019 S. Karger AG, Basel

          Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

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

          Cardiovascular Medicine, Nephrology

          Soluble CD40, Polymethylmethacrylate, Hepatitis B

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