PMID- 30843046
OWN - NLM
STAT- MEDLINE
DCOM- 20210106
LR  - 20220531
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Print)
IS  - 1058-4838 (Linking)
VI  - 70
IP  - 2
DP  - 2020 Jan 2
TI  - Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in 
      Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, 
      Randomized Clinical Trial.
PG  - 181-190
LID - 10.1093/cid/ciz177 [doi]
AB  - BACKGROUND: The incidence of herpes zoster is up to 9 times higher in 
      immunosuppressed solid organ transplant recipients than in the general 
      population. We investigated the immunogenicity and safety of an adjuvanted 
      recombinant zoster vaccine (RZV) in renal transplant (RT) recipients >/=18 years of 
      age receiving daily immunosuppressive therapy. METHODS: In this phase 3, 
      randomized (1:1), observer-blind, multicenter trial, RT recipients were enrolled 
      and received 2 doses of RZV or placebo 1-2 months (M) apart 4-18M posttransplant. 
      Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 T-cell 
      frequencies, and vaccine response rates were assessed at 1M post-dose 1, and 1M 
      and 12M post-dose 2. Solicited and unsolicited adverse events (AEs) were recorded 
      for 7 and 30 days after each dose, respectively. Solicited general symptoms and 
      unsolicited AEs were also collected 7 days before first vaccination. Serious AEs 
      (including biopsy-proven allograft rejections) and potential immune-mediated 
      diseases (pIMDs) were recorded up to 12M post-dose 2. RESULTS: Two hundred 
      sixty-four participants (RZV: 132; placebo: 132) were enrolled between March 2014 
      and April 2017. gE-specific humoral and cell-mediated immune responses were 
      higher in RZV than placebo recipients across postvaccination time points and 
      persisted above prevaccination baseline 12M post-dose 2. Local AEs were reported 
      more frequently by RZV than placebo recipients. Overall occurrences of renal 
      function changes, rejections, unsolicited AEs, serious AEs, and pIMDs were 
      similar between groups. CONCLUSIONS: RZV was immunogenic in chronically 
      immunosuppressed RT recipients. Immunogenicity persisted through 12M 
      postvaccination. No safety concerns arose. CLINICAL TRIALS REGISTRATION: 
      NCT02058589.
CI  - (c) The Author(s) 2019. Published by Oxford University Press for the Infectious 
      Diseases Society of America.
FAU - Vink, Peter
AU  - Vink P
AD  - GlaxoSmithKline (GSK), Rockville, Maryland.
FAU - Ramon Torrell, Josep Maria
AU  - Ramon Torrell JM
AD  - Bellvitge University Hospital, Barcelona.
FAU - Sanchez Fructuoso, Ana
AU  - Sanchez Fructuoso A
AD  - Hospital Clinico San Carlos, Madrid, Spain.
FAU - Kim, Sung-Joo
AU  - Kim SJ
AD  - Sungkyunkwan University, Canada.
FAU - Kim, Sang-Il
AU  - Kim SI
AD  - Seoul St Mary's Hospital, College of Medicine, Catholic University of Korea, 
      Republic of Korea.
FAU - Zaltzman, Jeff
AU  - Zaltzman J
AD  - St Michael's Hospital, University of Toronto, Ontario, Canada.
FAU - Ortiz, Fernanda
AU  - Ortiz F
AD  - Helsinki University Hospital, Finland.
FAU - Campistol Plana, Josep Maria
AU  - Campistol Plana JM
AD  - Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomediques 
      August Pi i Sunyer.
FAU - Fernandez Rodriguez, Ana Maria
AU  - Fernandez Rodriguez AM
AD  - Hospital Ramon y Cajal, Madrid.
FAU - Rebollo Rodrigo, Henar
AU  - Rebollo Rodrigo H
AD  - University Hospital Valdecilla, Santander.
FAU - Campins Marti, Magda
AU  - Campins Marti M
AD  - Hospital Universitario Vall d'Hebron, Barcelona, Spain.
FAU - Perez, Rafael
AU  - Perez R
AD  - Social Security of Panama, Panama City.
FAU - Gonzalez Roncero, Francisco Manuel
AU  - Gonzalez Roncero FM
AD  - Hospital Universitario Virgen Rocio, Sevilla, Spain.
FAU - Kumar, Deepali
AU  - Kumar D
AD  - University Health Network, Toronto, Ontario, Canada.
FAU - Chiang, Yang-Jen
AU  - Chiang YJ
AD  - Chang Gung Memorial Hospital, Taoyuan, Taiwan.
FAU - Doucette, Karen
AU  - Doucette K
AD  - University of Alberta, Edmonton, Canada.
FAU - Pipeleers, Lissa
AU  - Pipeleers L
AD  - UZ Brussel, Belgium.
FAU - Aguera Morales, Maria Luisa
AU  - Aguera Morales ML
AD  - Hospital Universitario Reina Sofia, Cordoba.
FAU - Rodriguez-Ferrero, Maria Luisa
AU  - Rodriguez-Ferrero ML
AD  - Hospital General Universitario Gregorio Maranon, Madrid, Spain.
FAU - Secchi, Antonio
AU  - Secchi A
AD  - Vita Salute San Reffaele University, Milan, Italy.
FAU - McNeil, Shelly A
AU  - McNeil SA
AD  - Canadian Center for Vaccinology, Izaak Walton Killam Health Centre and Nova 
      Scotia Health Authority, Dalhousie University, Halifax, Canada.
FAU - Campora, Laura
AU  - Campora L
AD  - GSK, Wavre, Belgium.
FAU - Di Paolo, Emmanuel
AU  - Di Paolo E
AD  - GSK, Rixensart, Belgium.
FAU - El Idrissi, Mohamed
AU  - El Idrissi M
AD  - GSK, Rixensart, Belgium.
FAU - Lopez-Fauqued, Marta
AU  - Lopez-Fauqued M
AD  - GSK, Wavre, Belgium.
FAU - Salaun, Bruno
AU  - Salaun B
AD  - GSK, Rixensart, Belgium.
FAU - Heineman, Thomas C
AU  - Heineman TC
AD  - GSK, King of Prussia, Pennsylvania.
FAU - Oostvogels, Lidia
AU  - Oostvogels L
AD  - GSK, Wavre, Belgium.
CN  - Z-041 Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT02058589
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - 0 (Antibodies, Viral)
RN  - 0 (Herpes Zoster Vaccine)
RN  - 0 (Vaccines, Synthetic)
SB  - IM
CIN - Clin Infect Dis. 2020 Jan 2;70(2):191-192. PMID: 30843045
CIN - Clin Infect Dis. 2020 Feb 3;70(4):719. PMID: 31340381
CIN - Clin Infect Dis. 2020 Feb 3;70(4):720-721. PMID: 31504292
CIN - Clin Infect Dis. 2020 Feb 3;70(4):718-719. PMID: 31504313
MH  - Adult
MH  - Antibodies, Viral
MH  - *Herpes Zoster/prevention & control
MH  - *Herpes Zoster Vaccine
MH  - Herpesvirus 3, Human
MH  - Humans
MH  - *Immunogenicity, Vaccine
MH  - *Kidney Transplantation
MH  - Vaccines, Synthetic/adverse effects
PMC - PMC6938982
OTO - NOTNLM
OT  - herpes zoster vaccine
OT  - immunogenicity
OT  - immunosuppression
OT  - renal transplant
OT  - safety
EDAT- 2019/03/08 06:00
MHDA- 2021/01/07 06:00
PMCR- 2019/03/07
CRDT- 2019/03/08 06:00
PHST- 2018/10/18 00:00 [received]
PHST- 2019/02/28 00:00 [accepted]
PHST- 2019/03/08 06:00 [pubmed]
PHST- 2021/01/07 06:00 [medline]
PHST- 2019/03/08 06:00 [entrez]
PHST- 2019/03/07 00:00 [pmc-release]
AID - 5370445 [pii]
AID - ciz177 [pii]
AID - 10.1093/cid/ciz177 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2020 Jan 2;70(2):181-190. doi: 10.1093/cid/ciz177.