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http://hdl.handle.net/2445/172559
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DC Field | Value | Language |
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dc.contributor.author | Vink, Peter | - |
dc.contributor.author | Ramon Torrell, Josep M. (Josep Maria) | - |
dc.contributor.author | Sánchez Fructuoso, Ana | - |
dc.contributor.author | Kim, Sung-Joo | - |
dc.contributor.author | Kim, Sang-il | - |
dc.contributor.author | Zaltzman, Jeff | - |
dc.contributor.author | Ortiz, Fernanda | - |
dc.contributor.author | Campistol Plana, Josep M. | - |
dc.contributor.author | Fernandez Rodriguez, Ana Maria | - |
dc.contributor.author | Rebollo Rodrigo, Henar | - |
dc.contributor.author | Campins Martí, Magda | - |
dc.contributor.author | Perez, Rafael | - |
dc.contributor.author | González Roncero, Francisco Manuel | - |
dc.contributor.author | Kumar, Deepali | - |
dc.contributor.author | Chiang, Jen | - |
dc.contributor.author | Doucette, Karen | - |
dc.contributor.author | Pipeleers, Lissa | - |
dc.contributor.author | Agüera Morales, Maria Luisa | - |
dc.contributor.author | Rodriguez-Ferrero, Maria Luisa | - |
dc.contributor.author | Secchi, Antonio | - |
dc.contributor.author | McNeil, Shelly A. | - |
dc.contributor.author | Campora, Laura | - |
dc.contributor.author | Paolo, Emmanuel Di | - |
dc.contributor.author | Idrissi, Mohamed El | - |
dc.contributor.author | López-Fauqued, Marta | - |
dc.contributor.author | Salaun, Bruno | - |
dc.contributor.author | Heineman, Thomas C. | - |
dc.contributor.author | Oostvogels, Lidia | - |
dc.contributor.author | Z-041 Study Group | - |
dc.date.accessioned | 2020-12-04T11:54:32Z | - |
dc.date.available | 2020-12-04T11:54:32Z | - |
dc.date.issued | 2019-03-07 | - |
dc.identifier.issn | 1058-4838 | - |
dc.identifier.uri | http://hdl.handle.net/2445/172559 | - |
dc.description.abstract | 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 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 III, randomized (1:1), observer-blind, multicenter trial (NCT02058589), RT recipients were enrolled and received 2 doses of RZV or Placebo 1-2 months (M) apart 4-18M post-transplant. 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 post-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: 264 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 post-vaccination time points and persisted above pre-vaccination 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, SAEs, and pIMDs were similar between groups. Conclusions: RZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M post-vaccination. No safety concerns arose. | - |
dc.format.extent | 10 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Oxford University Press | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1093/cid/ciz177 | - |
dc.relation.ispartof | Clinical Infectious Diseases, 2019, vol. 70, num. 2, p. 181-190 | - |
dc.relation.uri | https://doi.org/10.1093/cid/ciz177 | - |
dc.rights | cc by (c) Vink et al., 2019 | - |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es/ | - |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | Herpes zòster | - |
dc.subject.classification | Trasplantament renal | - |
dc.subject.classification | Immunosupressors | - |
dc.subject.other | Shingles (Disease) | - |
dc.subject.other | Kidney transplantation | - |
dc.subject.other | Immunosupressive agents | - |
dc.title | Immunogenicity and safety of adjuvanted recombinant zoster vaccine in chronically immunosuppresed adults following renal transplant: A phase III, randomized clinical trial | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 691359 | - |
dc.date.updated | 2020-12-04T11:54:32Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 30843046 | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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