• Something wrong with this record ?

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

A. Bastidas, J. de la Serna, M. El Idrissi, L. Oostvogels, P. Quittet, J. López-Jiménez, F. Vural, D. Pohlreich, T. Zuckerman, NC. Issa, G. Gaidano, JJ. Lee, S. Abhyankar, C. Solano, J. Perez de Oteyza, MJ. Satlin, S. Schwartz, M. Campins, A....

. 2019 ; 322 (2) : 123-133. [pub] 20190709

Language English Country United States

Document type Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc19034459

Importance: 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. Objective: To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients. Design, Setting, and Participants: 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. Interventions: 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. Main Outcomes and Measures: The primary end point was occurrence of confirmed herpes zoster cases. Results: 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. Conclusions and Relevance: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT01610414.

Brigham and Women's Hospital Dana Farber Cancer Institute Boston Massachusetts

Centro Integral Oncológico Clara Campal Universidad CEU San Pablo Madrid Spain

Charles University Hospital Prague Czech Republic

Chonnam National University Hwasun Hospital Jellanamdo Republic of Korea

CureVac AG Tübingen Germany

Department of Clinical Haematology Austin Health Heidelberg Australia

Department of Hematology and Oncology Charité University Medical Center Berlin Germany

Department of Internal Medicine Seoul St Mary's Hospital College of Medicine Catholic University of Korea Seoul South Korea

Department of Translational Medicine University of Eastern Piedmont Novara Italy

Duke University Medical Center Durham North Carolina

Ege University Medical School Izmir Turkey

Fred Hutchinson Cancer Research Center Seattle Washington

GlaxoSmithKline Rixensart Belgium

GlaxoSmithKline Wavre Belgium

Haematology Department Manchester University NHS Foundation Trust Manchester Royal Infirmary Manchester England Faculty of Biology Medicine and Health School of Medical Science Division of Cancer Sciences University of Manchester Manchester England

Halozyme Therapeutics San Diego California

Hospital Ampang Selangor Malaysia

Hospital Clínico Universitario School of Medicine University of Valencia Valencia Spain

Hospital de Donostia San Sebastián Spain

Hospital Ramón y Cajal Madrid Spain

Hospital Universitario 12 de Octubre Madrid Spain

Preventive Medicine and Epidemiology Department University Hospital Vall d'Hebron Barcelona Spain

Rambam Health Care Campus Haifa Israel

Royal Hobart Hospital Hobart Australia

University Hospital of Montpellier Montpellier France

University of Kansas Cancer Center Westwood

University of Pennsylvania Philadelphia

Weill Medical College of Cornell University New York New York

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc19034459
003      
CZ-PrNML
005      
20191014110629.0
007      
ta
008      
191007s2019 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1001/jama.2019.9053 $2 doi
035    __
$a (PubMed)31287523
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Bastidas, Adriana $u GlaxoSmithKline, Wavre, Belgium.
245    10
$a Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial / $c A. Bastidas, J. de la Serna, M. El Idrissi, L. Oostvogels, P. Quittet, J. López-Jiménez, F. Vural, D. Pohlreich, T. Zuckerman, NC. Issa, G. Gaidano, JJ. Lee, S. Abhyankar, C. Solano, J. Perez de Oteyza, MJ. Satlin, S. Schwartz, M. Campins, A. Rocci, C. Vallejo Llamas, DG. Lee, SM. Tan, AM. Johnston, A. Grigg, MJ. Boeckh, L. Campora, M. Lopez-Fauqued, TC. Heineman, EA. Stadtmauer, KM. Sullivan, ZOE-HSCT Study Group Collaborators,
520    9_
$a Importance: 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. Objective: To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients. Design, Setting, and Participants: 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. Interventions: 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. Main Outcomes and Measures: The primary end point was occurrence of confirmed herpes zoster cases. Results: 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. Conclusions and Relevance: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT01610414.
650    _2
$a adjuvancia imunologická $7 D000276
650    _2
$a dospělí $7 D000328
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a následné studie $7 D005500
650    12
$a transplantace hematopoetických kmenových buněk $7 D018380
650    _2
$a herpes zoster $x epidemiologie $x prevence a kontrola $7 D006562
650    12
$a vakcína proti pásovému oparu $x aplikace a dávkování $7 D053061
650    _2
$a hospitalizace $x statistika a číselné údaje $7 D006760
650    _2
$a lidé $7 D006801
650    12
$a imunokompromitovaný pacient $7 D016867
650    _2
$a incidence $7 D015994
650    _2
$a injekce intramuskulární $7 D007273
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a postherpetická neuralgie $x prevence a kontrola $7 D051474
650    _2
$a proporcionální rizikové modely $7 D016016
650    _2
$a jednoduchá slepá metoda $7 D016037
650    _2
$a autologní transplantace $7 D014182
650    _2
$a syntetické vakcíny $x aplikace a dávkování $7 D014614
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a srovnávací studie $7 D003160
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a randomizované kontrolované studie $7 D016449
700    1_
$a de la Serna, Javier $u Hospital Universitario 12 de Octubre, Madrid, Spain.
700    1_
$a El Idrissi, Mohamed $u GlaxoSmithKline, Rixensart, Belgium.
700    1_
$a Oostvogels, Lidia $u CureVac AG, Tübingen, Germany.
700    1_
$a Quittet, Philippe $u University Hospital of Montpellier, Montpellier, France.
700    1_
$a López-Jiménez, Javier $u Hospital Ramón y Cajal, Madrid, Spain.
700    1_
$a Vural, Filiz $u Ege University Medical School, Izmir, Turkey.
700    1_
$a Pohlreich, David $u Charles University Hospital, Prague, Czech Republic.
700    1_
$a Zuckerman, Tsila $u Rambam Health Care Campus, Haifa, Israel.
700    1_
$a Issa, Nicolas C $u Brigham and Women's Hospital/Dana-Farber Cancer Institute, Boston, Massachusetts.
700    1_
$a Gaidano, Gianluca $u Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.
700    1_
$a Lee, Je-Jung $u Chonnam National University Hwasun Hospital, Jellanamdo, Republic of Korea.
700    1_
$a Abhyankar, Sunil $u University of Kansas Cancer Center, Westwood.
700    1_
$a Solano, Carlos $u Hospital Clínico Universitario, School of Medicine, University of Valencia, Valencia, Spain.
700    1_
$a Perez de Oteyza, Jaime $u Centro Integral Oncológico Clara Campal (CIOCC), Universidad CEU San Pablo, Madrid, Spain.
700    1_
$a Satlin, Michael J $u Weill Medical College of Cornell University, New York, New York.
700    1_
$a Schwartz, Stefan $u Department of Hematology and Oncology, Charité University Medical Center, Berlin, Germany.
700    1_
$a Campins, Magda $u Preventive Medicine and Epidemiology Department, University Hospital Vall d'Hebron, Barcelona, Spain.
700    1_
$a Rocci, Alberto $u Haematology Department, Manchester University NHS Foundation Trust, Manchester Royal Infirmary, Manchester, England. Faculty of Biology, Medicine and Health, School of Medical Science, Division of Cancer Sciences, University of Manchester, Manchester, England.
700    1_
$a Vallejo Llamas, Carlos $u Hospital de Donostia, San Sebastián, Spain.
700    1_
$a Lee, Dong-Gun $u Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, Catholic University of Korea, Seoul, South Korea.
700    1_
$a Tan, Sen Mui $u Hospital Ampang, Selangor, Malaysia.
700    1_
$a Johnston, Anna M $u Royal Hobart Hospital, Hobart, Australia.
700    1_
$a Grigg, Andrew $u Department of Clinical Haematology, Austin Health, Heidelberg, Australia.
700    1_
$a Boeckh, Michael J $u Fred Hutchinson Cancer Research Center, Seattle, Washington.
700    1_
$a Campora, Laura $u GlaxoSmithKline, Wavre, Belgium.
700    1_
$a Lopez-Fauqued, Marta $u GlaxoSmithKline, Wavre, Belgium.
700    1_
$a Heineman, Thomas C $u Halozyme Therapeutics, San Diego, California.
700    1_
$a Stadtmauer, Edward A $u University of Pennsylvania, Philadelphia.
700    1_
$a Sullivan, Keith M $u Duke University Medical Center, Durham, North Carolina.
710    2_
$a ZOE-HSCT Study Group Collaborators
773    0_
$w MED00002973 $t JAMA $x 1538-3598 $g Roč. 322, č. 2 (2019), s. 123-133
856    41
$u https://pubmed.ncbi.nlm.nih.gov/31287523 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20191007 $b ABA008
991    __
$a 20191014111054 $b ABA008
999    __
$a ok $b bmc $g 1451119 $s 1073009
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2019 $b 322 $c 2 $d 123-133 $e 20190709 $i 1538-3598 $m JAMA (Chicago, Ill.) $n JAMA $x MED00002973
LZP    __
$a Pubmed-20191007

Find record

Citation metrics

Archiving options