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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2020
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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. |
format | Online Article Text |
id | pubmed-6938982 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
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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