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      Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation : A Randomized Clinical Trial

      1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 1 , 1 , 27 , 28 , 29 , for the ZOE-HSCT Study Group Collaborators
      JAMA
      American Medical Association (AMA)

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          Abstract

          Herpes zoster, a frequent complication following autologous hematopoietic stem cell transplantation (HSCT), is associated with significant morbidity. A nonlive adjuvanted recombinant zoster vaccine has been developed to prevent posttransplantation zoster.

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          Most cited references18

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          Vaccination of hematopoietic cell transplant recipients.

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            Is Open Access

            Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older

            Abstract Background The herpes zoster subunit vaccine (HZ/su), consisting of varicella-zoster virus glycoprotein E (gE) and AS01B Adjuvant System, was highly efficacious in preventing herpes zoster in the ZOE-50 and ZOE-70 trials. We present immunogenicity results from those trials. Methods Participants (ZOE-50: ≥50; ZOE-70: ≥70 years of age) received 2 doses of HZ/su or placebo, 2 months apart. Serum anti-gE antibodies and CD4 T cells expressing ≥2 of 4 activation markers assessed (CD42+) after stimulation with gE-peptides were measured in subcohorts for humoral (n = 3293) and cell-mediated (n = 466) immunogenicity. Results After vaccination, 97.8% of HZ/su and 2.0% of placebo recipients showed a humoral response. Geometric mean anti-gE antibody concentrations increased 39.1-fold and 8.3-fold over baseline in HZ/su recipients at 1 and 36 months post-dose 2, respectively. A gE-specific CD42+ T-cell response was shown in 93.3% of HZ/su and 0% of placebo recipients. Median CD42+ T-cell frequencies increased 24.6-fold (1 month) and 7.9-fold (36 months) over baseline in HZ/su recipients and remained ≥5.6-fold above baseline in all age groups at 36 months. The proportion of CD4 T cells expressing all 4 activation markers increased over time in all age groups. Conclusions Most HZ/su recipients developed robust immune responses persisting for 3 years following vaccination. Clinical Trials Registration NCT01165177; NCT01165229.
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              Development of adjuvanted recombinant zoster vaccine and its implications for shingles prevention

              GSK has developed a two-dose adjuvanted recombinant zoster vaccine (Shingrix, RZV) to protect people aged ≥50 years (50+) against herpes zoster (HZ) and its complications. RZV showed >90% efficacy against HZ, sustained over 4 years of follow-up, in all studied age groups.
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                Author and article information

                Journal
                JAMA
                JAMA
                American Medical Association (AMA)
                0098-7484
                July 09 2019
                July 09 2019
                : 322
                : 2
                : 123
                Affiliations
                [1 ]GlaxoSmithKline, Wavre, Belgium
                [2 ]Hospital Universitario 12 de Octubre, Madrid, Spain
                [3 ]GlaxoSmithKline, Rixensart, Belgium
                [4 ]CureVac AG, Tübingen, Germany
                [5 ]University Hospital of Montpellier, Montpellier, France
                [6 ]Hospital Ramón y Cajal, Madrid, Spain
                [7 ]Ege University Medical School, Izmir, Turkey
                [8 ]Charles University Hospital, Prague, Czech Republic
                [9 ]Rambam Health Care Campus, Haifa, Israel
                [10 ]Brigham and Women’s Hospital/Dana-Farber Cancer Institute, Boston, Massachusetts
                [11 ]Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy
                [12 ]Chonnam National University Hwasun Hospital, Jellanamdo, Republic of Korea
                [13 ]University of Kansas Cancer Center, Westwood
                [14 ]Hospital Clínico Universitario, School of Medicine, University of Valencia, Valencia, Spain
                [15 ]Centro Integral Oncológico Clara Campal (CIOCC), Universidad CEU San Pablo, Madrid, Spain
                [16 ]Weill Medical College of Cornell University, New York, New York
                [17 ]Department of Hematology and Oncology, Charité University Medical Center, Berlin, Germany
                [18 ]Preventive Medicine and Epidemiology Department, University Hospital Vall d’Hebron, Barcelona, Spain
                [19 ]Haematology Department, Manchester University NHS Foundation Trust, Manchester Royal Infirmary, Manchester, England
                [20 ]Faculty of Biology, Medicine and Health, School of Medical Science, Division of Cancer Sciences, University of Manchester, Manchester, England
                [21 ]Hospital de Donostia, San Sebastián, Spain
                [22 ]Department of Internal Medicine, Seoul St Mary’s Hospital, College of Medicine, Catholic University of Korea, Seoul, South Korea
                [23 ]Hospital Ampang, Selangor, Malaysia
                [24 ]Royal Hobart Hospital, Hobart, Australia
                [25 ]Department of Clinical Haematology, Austin Health, Heidelberg, Australia
                [26 ]Fred Hutchinson Cancer Research Center, Seattle, Washington
                [27 ]Halozyme Therapeutics, San Diego, California
                [28 ]University of Pennsylvania, Philadelphia
                [29 ]Duke University Medical Center, Durham, North Carolina
                Article
                10.1001/jama.2019.9053
                6618796
                31287523
                9400621f-84d1-4b9c-aa15-56af2df28e63
                © 2019
                History

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