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      A randomized pilot trial on the effect of granulocyte-colony stimulating factor on antibody response in hemodialysis patients who had not responded to routine hepatitis B virus vaccine

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          Abstract

          Background: Various strategies have been applied to improve the response to hepatitis B virus (HBV) vaccination in hemodialysis patients.

          Objectives: The present study was under taken to compare the seroconversion rate of hemodialysis patients who had not respond to 3 intramuscular (IM) doses (40 μg each) of HBV vaccine , after a fourth IM dose (40 μg) of HBV vaccine that was administered alone or with subcutaneous granulocyte-colony stimulating factor (G-CSF) (5 μg/kg).

          Patients and Methods: Twenty six hemodialysis patients who had not responded to 3 IM injections of HBV vaccine were randomized into 2 groups: Group 1 received a booster dose of 40 μg HBV vaccine IM, group 2 received a booster dose of 40 μg HBV vaccine IM plus 5 μg/kg subcutaneous G-CSF. Antibody to hepatitis B surface antigen was measured 1 month after the booster dose.

          Results: Seroconversion rate in group 1 was 40%. There was a trend towards a higher seroconversion rate at 60% in group 2 patients; however, because of the small number of patients it did not reach statistical significance.

          Conclusions: Larger number of patients and other innovative strategies should be applied for vaccination of this group of patients. More prolonged follow up of the patients is needed to evaluate the duration of protection induced by each method of vaccination.

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          Clinical practice: prevention of hepatitis B with the hepatitis B vaccine.

          Gregory A. Poland, Robert M. Jacobson (2004)
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            Granulocyte-colony stimulating factor mobilizes T helper 2-inducing dendritic cells.

            S Heimfeld, C Green, I Heuser … (2000)
            Peripheral blood stem cells (PBSC) obtained from granulocyte-colony stimulating factor (G-CSF)-mobilized donors are increasingly used for allogeneic transplantation. Despite a 10-fold higher dose of transplanted T cells, acute graft-versus-host disease (GVHD) does not develop in higher proportion in recipients of PBSC than in recipients of marrow. T cells from G-CSF-treated experimental animals preferentially produce IL-4 and IL-10, cytokines characteristic of Th2 responses, which are associated with diminished GVHD-inducing ability. We hypothesized that G-CSF-mobilized PBSC contain antigen-presenting cells, which prime T-lymphocytes to produce Th2 cytokines. Two distinct lineages of dendritic cells (DC) have been described in humans, DC1 and DC2, according to their ability to induce naive T-cell differentiation to Th1 and Th2 effector cells, respectively. We have used multicolor microfluorometry to enumerate DC1 and DC2 in the peripheral blood of normal donors. G-CSF treatment with 10 to 16 microg/kg per day for 5 days increased peripheral blood DC2 counts from a median of 4.9 x 10(6)/L to 24.8 x 10(6)/L (P =.0009), whereas DC1 counts did not change. Purified DC1, from either untreated or G-CSF treated donors, induced the proliferation of allogeneic naive T cells, but fresh DC2 were poor stimulators. Tumor necrosis factor-alpha (TNF-alpha)-activated DC1 induced allogeneic naive T cells to produce IFN-gamma, which is typical of Th1 responses, whereas TNF-alpha-activated DC2 induced allogeneic naive T cells to produce IL-4 and IL-10, which are typical of Th2 responses. PBSC transplants contained higher doses of DC2 than marrow transplants (median, 2.4 x 10(6)/kg versus 0.5 x 10(6)/kg) (P =.006), whereas the dose of DC1 was comparable. Thus, it is conceivable that transplantation of G-CSF-stimulated PBSC does not result in overwhelming acute GVHD because the graft contains predominantly Th2-inducing DC. Adoptive transfer of purified DC2 may be exploited to induce immune deviation after transplantation of hematopoietic stem cells or organ allografts. (Blood. 2000;95:2484-2490)
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              Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients.

              J Novales, Terence Y-S Kee, Marc Lievens … (2005)
              Due to their impaired immune system, patients with renal insufficiency have a suboptimal response to hepatitis B (HB) vaccination and frequent boosters are needed to maintain protection. GlaxoSmithKline Biologicals has developed a HB vaccine containing a new adjuvant system AS04 for use in this immunocompromised patient population. In an open, randomized clinical trial conducted in pre-hemodialysis (documented creatinine clearance < or =30 mL/min) and hemodialysis patients, over 15 years of age and naïve for HB, the immunogenicity and safety of single doses of HB-AS04 (Fendrix, GlaxoSmithKline Biologicals) were compared to double doses of commercially available HB vaccine (Engerix, GlaxoSmithKline Biologicals) administered at 0, 1, 2, and 6 months, and followed-up for 36 months. The HB-AS04 vaccine elicited a more rapid onset of protection than the currently licensed vaccine for this particular population, with 74% versus 52% of subjects seroprotected at month 3. After the vaccination course, seroprotection rates increased to 91% versus 84% in the HB-AS04 and standard vaccine groups, respectively. Differences persisted up to 36 months post-vaccination (73% vs. 52%, respectively). Antibody concentrations were higher following the HB-AS04 vaccine at all post-vaccination time points. During the follow-up, significantly fewer subjects primed with the HB-AS04 vaccine needed a booster dose as a consequence of anti-HBs loss below seroprotective levels (11/62 subjects in the HB-AS04 group vs. 22/57 subjects in the standard vaccine group, respectively, P = 0.014). The HB-AS04 was more locally reactogenic than the standard immunization regimen, with pain at the injection site occurring with 41% of HB-AS04 doses versus 19% of standard vaccine doses. The occurrence of grade 3 pain was less than 1% in both groups and all events resolved within the 4-day follow-up period. The improved immunogenicity profile and clinically acceptable reactogenicity of HB-AS04 vaccine are of key importance to provide a more rapid, enhanced, and longer seroprotection to these immunocompromised patients at risk for HB infection.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Nephropathol
                Journal ID (iso-abbrev): J Nephropathol
                Journal ID (publisher-id): J Nephropathol
                Journal ID (pmc): J Nephropathol
                Journal ID (publisher-id): JNP
                Title: Journal of Nephropathology
                Publisher: Society of Diabetic Nephropathy Prevention
                ISSN (Print): 2251-8363
                ISSN (Electronic): 2251-8819
                Publication date (Print): January 2015
                Publication date (Electronic): 01 January 2015
                Volume: 4
                Issue: 1
                Pages: 13-17
                Affiliations
                1Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
                2Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
                3Health Policy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
                4Department of Dental Public Health, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran
                5Division of Nephrology, Saint Louis University, School of Medicine, Saint Louis, Missouri, USA
                Author notes
                [* ] Corresponding author: Prof. Bahar Bastani, Division of Nephrology, Saint Louis University Health Sciences Center, Saint Louis, Missouri, USA. bastanib@ 123456slu.edu
                Article
                DOI: 10.12860/jnp.2015.03
                PMC ID: 4316580
                SO-VID: 09ebd2d6-7734-45c3-8bfb-380d19626449
                Copyright © © 2015 The Author(s)
                License:

                Published by Society of Diabetic Nephropathy Prevention. This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 07 September 2014
                Date accepted : 14 November 2014
                Page count
                Tables: 2, References: 39, Pages: 5
                Categories
                Subject: Original Article

                Keywords: granulocyte-colony stimulating factor,hemodialysis,vaccination,hepatitis b,granulocyte-macrophage colonystimulating
                Data availability:
                Keywords: granulocyte-colony stimulating factor, hemodialysis, vaccination, hepatitis b, granulocyte-macrophage colonystimulating

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