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Title: Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial.
Austin Authors: Bastidas, Adriana;de la Serna, Javier;El Idrissi, Mohamed;Oostvogels, Lidia;Quittet, Philippe;López-Jiménez, Javier;Vural, Filiz;Pohlreich, David;Zuckerman, Tsila;Issa, Nicolas C;Gaidano, Gianluca;Lee, Je-Jung;Abhyankar, Sunil;Solano, Carlos;Perez de Oteyza, Jaime;Satlin, Michael J;Schwartz, Stefan;Campins, Magda;Rocci, Alberto;Vallejo Llamas, Carlos;Lee, Dong-Gun;Tan, Sen Mui;Johnston, Anna M;Grigg, Andrew P ;Boeckh, Michael J;Campora, Laura;Lopez-Fauqued, Marta;Heineman, Thomas C;Stadtmauer, Edward A;Sullivan, Keith M
Affiliation: GlaxoSmithKline, Wavre, Belgium
Department of Clinical Haematology, Austin Health, Heidelberg, Victoria, Australia
Rambam Health Care Campus, Haifa, Israel
CureVac AG, Tübingen, Germany
Haematology Department, Manchester University NHS Foundation Trust, Manchester Royal Infirmary, Manchester, England
Department of Hematology and Oncology, Charité University Medical Center, Berlin, Germany
Weill Medical College of Cornell University, New York, New York, USA
University Hospital of Montpellier, Montpellier, France
Royal Hobart Hospital, Hobart, Australia
Faculty of Biology, Medicine and Health, School of Medical Science, Division of Cancer Sciences, University of Manchester, Manchester, England
Hospital Universitario 12 de Octubre, Madrid, Spain
GlaxoSmithKline, Rixensart, Belgium
Hospital Ramón y Cajal, Madrid, Spain
Ege University Medical School, Izmir, Turkey
Charles University Hospital, Prague, Czech Republic
Brigham and Women's Hospital/Dana-Farber Cancer Institute, Boston, Massachusetts
Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy
Chonnam National University Hwasun Hospital, Jellanamdo, Republic of Korea
University of Kansas Cancer Center, Westwood
Hospital Clínico Universitario, School of Medicine, University of Valencia, Valencia, Spain
Centro Integral Oncológico Clara Campal (CIOCC), Universidad CEU San Pablo, Madrid, Spain
Preventive Medicine and Epidemiology Department, University Hospital Vall d'Hebron, Barcelona, Spain
Hospital de Donostia, San Sebastián, Spain
Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, Catholic University of Korea, Seoul, South Korea
Hospital Ampang, Selangor, Malaysia
Fred Hutchinson Cancer Research Center, Seattle, Washington
GlaxoSmithKline, Wavre, Belgium
Halozyme Therapeutics, San Diego, California
University of Pennsylvania, Philadelphia
Duke University Medical Center, Durham, North Carolina
Issue Date: 9-Jul-2019
Publication information: JAMA 2019; 322(2): 123-133
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. To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients. Phase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT. Participants were randomized to receive 2 doses of either recombinant zoster vaccine (n = 922) or placebo (n = 924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter. The primary end point was occurrence of confirmed herpes zoster cases. Among 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P < .001), equivalent to 68.2% vaccine efficacy. Of 8 secondary end points, 3 showed significant reductions in incidence of postherpetic neuralgia (vaccine, n=1; placebo, n=9; IRR, 0.1; 95% CI, 0.00-0.78; P = .02) and of other prespecified herpes zoster-related complications (vaccine, n=3; placebo, n=13; IRR, 0.22; 95% CI, 0.04-0.81; P = .02) and in duration of severe worst herpes zoster-associated pain (vaccine, 892.0 days; placebo, 6275.0 days; hazard ratio, 0.62; 95% CI, 0.42-0.89; P = .01). Five secondary objectives were descriptive. Injection site reactions were recorded in 86% of vaccine and 10% of placebo recipients, of which pain was the most common, occurring in 84% of vaccine recipients (grade 3: 11%). Unsolicited and serious adverse events, potentially immune-mediated diseases, and underlying disease relapses were similar between groups at all time points. Among adults who had undergone autologous HSCT, a 2-dose course of recombinant zoster vaccine compared with placebo significantly reduced the incidence of herpes zoster over a median follow-up of 21 months. Identifier: NCT01610414.
DOI: 10.1001/jama.2019.9053
Journal: JAMA
PubMed URL: 31287523
Type: Journal Article
Appears in Collections:Journal articles

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