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Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial

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 ag...

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Autores principales: Vink, Peter, Ramon Torrell, Josep Maria, Sanchez Fructuoso, Ana, Kim, Sung-Joo, Kim, Sang-il, Zaltzman, Jeff, Ortiz, Fernanda, Campistol Plana, Josep Maria, Fernandez Rodriguez, Ana Maria, Rebollo Rodrigo, Henar, Campins Marti, Magda, Perez, Rafael, González Roncero, Francisco Manuel, Kumar, Deepali, Chiang, Yang-Jen, Doucette, Karen, Pipeleers, Lissa, Agüera Morales, Maria Luisa, Rodriguez-Ferrero, Maria Luisa, Secchi, Antonio, McNeil, Shelly A, Campora, Laura, Di Paolo, Emmanuel, El Idrissi, Mohamed, López-Fauqued, Marta, Salaun, Bruno, Heineman, Thomas C, Oostvogels, Lidia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6938982/
https://www.ncbi.nlm.nih.gov/pubmed/30843046
http://dx.doi.org/10.1093/cid/ciz177
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author Vink, Peter
Ramon Torrell, Josep Maria
Sanchez Fructuoso, Ana
Kim, Sung-Joo
Kim, Sang-il
Zaltzman, Jeff
Ortiz, Fernanda
Campistol Plana, Josep Maria
Fernandez Rodriguez, Ana Maria
Rebollo Rodrigo, Henar
Campins Marti, Magda
Perez, Rafael
González Roncero, Francisco Manuel
Kumar, Deepali
Chiang, Yang-Jen
Doucette, Karen
Pipeleers, Lissa
Agüera Morales, Maria Luisa
Rodriguez-Ferrero, Maria Luisa
Secchi, Antonio
McNeil, Shelly A
Campora, Laura
Di Paolo, Emmanuel
El Idrissi, Mohamed
López-Fauqued, Marta
Salaun, Bruno
Heineman, Thomas C
Oostvogels, Lidia
author_facet Vink, Peter
Ramon Torrell, Josep Maria
Sanchez Fructuoso, Ana
Kim, Sung-Joo
Kim, Sang-il
Zaltzman, Jeff
Ortiz, Fernanda
Campistol Plana, Josep Maria
Fernandez Rodriguez, Ana Maria
Rebollo Rodrigo, Henar
Campins Marti, Magda
Perez, Rafael
González Roncero, Francisco Manuel
Kumar, Deepali
Chiang, Yang-Jen
Doucette, Karen
Pipeleers, Lissa
Agüera Morales, Maria Luisa
Rodriguez-Ferrero, Maria Luisa
Secchi, Antonio
McNeil, Shelly A
Campora, Laura
Di Paolo, Emmanuel
El Idrissi, Mohamed
López-Fauqued, Marta
Salaun, Bruno
Heineman, Thomas C
Oostvogels, Lidia
author_sort Vink, Peter
collection PubMed
description 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.
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spelling pubmed-69389822020-01-07 Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial Vink, Peter Ramon Torrell, Josep Maria Sanchez Fructuoso, Ana Kim, Sung-Joo Kim, Sang-il Zaltzman, Jeff Ortiz, Fernanda Campistol Plana, Josep Maria Fernandez Rodriguez, Ana Maria Rebollo Rodrigo, Henar Campins Marti, Magda Perez, Rafael González Roncero, Francisco Manuel Kumar, Deepali Chiang, Yang-Jen Doucette, Karen Pipeleers, Lissa Agüera Morales, Maria Luisa Rodriguez-Ferrero, Maria Luisa Secchi, Antonio McNeil, Shelly A Campora, Laura Di Paolo, Emmanuel El Idrissi, Mohamed López-Fauqued, Marta Salaun, Bruno Heineman, Thomas C Oostvogels, Lidia Clin Infect Dis Articles and Commentaries 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. Oxford University Press 2020-01-15 2019-03-07 /pmc/articles/PMC6938982/ /pubmed/30843046 http://dx.doi.org/10.1093/cid/ciz177 Text en © The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Articles and Commentaries
Vink, Peter
Ramon Torrell, Josep Maria
Sanchez Fructuoso, Ana
Kim, Sung-Joo
Kim, Sang-il
Zaltzman, Jeff
Ortiz, Fernanda
Campistol Plana, Josep Maria
Fernandez Rodriguez, Ana Maria
Rebollo Rodrigo, Henar
Campins Marti, Magda
Perez, Rafael
González Roncero, Francisco Manuel
Kumar, Deepali
Chiang, Yang-Jen
Doucette, Karen
Pipeleers, Lissa
Agüera Morales, Maria Luisa
Rodriguez-Ferrero, Maria Luisa
Secchi, Antonio
McNeil, Shelly A
Campora, Laura
Di Paolo, Emmanuel
El Idrissi, Mohamed
López-Fauqued, Marta
Salaun, Bruno
Heineman, Thomas C
Oostvogels, Lidia
Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial
title Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial
title_full Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial
title_fullStr Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial
title_full_unstemmed Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial
title_short Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial
title_sort immunogenicity and safety of the adjuvanted recombinant zoster vaccine in chronically immunosuppressed adults following renal transplant: a phase 3, randomized clinical trial
topic Articles and Commentaries
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6938982/
https://www.ncbi.nlm.nih.gov/pubmed/30843046
http://dx.doi.org/10.1093/cid/ciz177
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