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dc.contributor.authorBastidas, Adriana-
dc.contributor.authorde la Serna, Javier-
dc.contributor.authorEl Idrissi, Mohamed-
dc.contributor.authorOostvogels, Lidia-
dc.contributor.authorQuittet, Philippe-
dc.contributor.authorLópez-Jiménez, Javier-
dc.contributor.authorVural, Filiz-
dc.contributor.authorPohlreich, David-
dc.contributor.authorZuckerman, Tsila-
dc.contributor.authorIssa, Nicolas C-
dc.contributor.authorGaidano, Gianluca-
dc.contributor.authorLee, Je-Jung-
dc.contributor.authorAbhyankar, Sunil-
dc.contributor.authorSolano, Carlos-
dc.contributor.authorPerez de Oteyza, Jaime-
dc.contributor.authorSatlin, Michael J-
dc.contributor.authorSchwartz, Stefan-
dc.contributor.authorCampins, Magda-
dc.contributor.authorRocci, Alberto-
dc.contributor.authorVallejo Llamas, Carlos-
dc.contributor.authorLee, Dong-Gun-
dc.contributor.authorTan, Sen Mui-
dc.contributor.authorJohnston, Anna M-
dc.contributor.authorGrigg, Andrew P-
dc.contributor.authorBoeckh, Michael J-
dc.contributor.authorCampora, Laura-
dc.contributor.authorLopez-Fauqued, Marta-
dc.contributor.authorHeineman, Thomas C-
dc.contributor.authorStadtmauer, Edward A-
dc.contributor.authorSullivan, Keith M-
dc.identifier.citationJAMA 2019; 322(2): 123-133-
dc.description.abstractHerpes 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.-
dc.titleEffect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial.-
dc.typeJournal Article-
dc.identifier.affiliationGlaxoSmithKline, Wavre, Belgium-
dc.identifier.affiliationDepartment of Clinical Haematology, Austin Health, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationRambam Health Care Campus, Haifa, Israelen
dc.identifier.affiliationCureVac AG, Tübingen, Germanyen
dc.identifier.affiliationHaematology Department, Manchester University NHS Foundation Trust, Manchester Royal Infirmary, Manchester, Englanden
dc.identifier.affiliationDepartment of Hematology and Oncology, Charité University Medical Center, Berlin, Germanyen
dc.identifier.affiliationWeill Medical College of Cornell University, New York, New York, USAen
dc.identifier.affiliationUniversity Hospital of Montpellier, Montpellier, Franceen
dc.identifier.affiliationRoyal Hobart Hospital, Hobart, Australiaen
dc.identifier.affiliationFaculty of Biology, Medicine and Health, School of Medical Science, Division of Cancer Sciences, University of Manchester, Manchester, Englanden
dc.identifier.affiliationHospital Universitario 12 de Octubre, Madrid, Spain-
dc.identifier.affiliationGlaxoSmithKline, Rixensart, Belgium-
dc.identifier.affiliationHospital Ramón y Cajal, Madrid, Spain-
dc.identifier.affiliationEge University Medical School, Izmir, Turkey-
dc.identifier.affiliationCharles University Hospital, Prague, Czech Republic-
dc.identifier.affiliationBrigham and Women's Hospital/Dana-Farber Cancer Institute, Boston, Massachusetts-
dc.identifier.affiliationDepartment of Translational Medicine, University of Eastern Piedmont, Novara, Italy-
dc.identifier.affiliationChonnam National University Hwasun Hospital, Jellanamdo, Republic of Korea-
dc.identifier.affiliationUniversity of Kansas Cancer Center, Westwood-
dc.identifier.affiliationHospital Clínico Universitario, School of Medicine, University of Valencia, Valencia, Spain-
dc.identifier.affiliationCentro Integral Oncológico Clara Campal (CIOCC), Universidad CEU San Pablo, Madrid, Spain-
dc.identifier.affiliationPreventive Medicine and Epidemiology Department, University Hospital Vall d'Hebron, Barcelona, Spain-
dc.identifier.affiliationHospital de Donostia, San Sebastián, Spain-
dc.identifier.affiliationDepartment of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, Catholic University of Korea, Seoul, South Korea-
dc.identifier.affiliationHospital Ampang, Selangor, Malaysia-
dc.identifier.affiliationFred Hutchinson Cancer Research Center, Seattle, Washington-
dc.identifier.affiliationGlaxoSmithKline, Wavre, Belgium-
dc.identifier.affiliationHalozyme Therapeutics, San Diego, California-
dc.identifier.affiliationUniversity of Pennsylvania, Philadelphia-
dc.identifier.affiliationDuke University Medical Center, Durham, North Carolina-
dc.type.austinClinical Trial, Phase III-
dc.type.austinComparative Study-
dc.type.austinJournal Article-
dc.type.austinMulticenter Study-
dc.type.austinRandomized Controlled Trial-, Andrew P
item.openairetypeJournal Article-
item.fulltextNo Fulltext-
item.languageiso639-1en- Newton-John Cancer Wellness and Research Centre- Haematology-
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