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Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial

BACKGROUND: The adjuvanted recombinant zoster vaccine (RZV) has demonstrated >90% efficacy against herpes zoster in adults ≥50 years of age and 68% efficacy in autologous hematopoietic stem cell transplant recipients ≥18 years of age. We report the immunogenicity and safety of RZV administered to...

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Autores principales: Vink, Peter, Delgado Mingorance, Ignacio, Maximiano Alonso, Constanza, Rubio‐Viqueira, Belen, Jung, Kyung Hae, Rodriguez Moreno, Juan Francisco, Grande, Enrique, Marrupe Gonzalez, David, Lowndes, Sarah, Puente, Javier, Kristeleit, Hartmut, Farrugia, David, McNeil, Shelly A., Campora, Laura, Di Paolo, Emmanuel, El Idrissi, Mohamed, Godeaux, Olivier, López‐Fauqued, Marta, Salaun, Bruno, Heineman, Thomas C., Oostvogels, Lidia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6766894/
https://www.ncbi.nlm.nih.gov/pubmed/30707761
http://dx.doi.org/10.1002/cncr.31909
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author Vink, Peter
Delgado Mingorance, Ignacio
Maximiano Alonso, Constanza
Rubio‐Viqueira, Belen
Jung, Kyung Hae
Rodriguez Moreno, Juan Francisco
Grande, Enrique
Marrupe Gonzalez, David
Lowndes, Sarah
Puente, Javier
Kristeleit, Hartmut
Farrugia, David
McNeil, Shelly A.
Campora, Laura
Di Paolo, Emmanuel
El Idrissi, Mohamed
Godeaux, Olivier
López‐Fauqued, Marta
Salaun, Bruno
Heineman, Thomas C.
Oostvogels, Lidia
author_facet Vink, Peter
Delgado Mingorance, Ignacio
Maximiano Alonso, Constanza
Rubio‐Viqueira, Belen
Jung, Kyung Hae
Rodriguez Moreno, Juan Francisco
Grande, Enrique
Marrupe Gonzalez, David
Lowndes, Sarah
Puente, Javier
Kristeleit, Hartmut
Farrugia, David
McNeil, Shelly A.
Campora, Laura
Di Paolo, Emmanuel
El Idrissi, Mohamed
Godeaux, Olivier
López‐Fauqued, Marta
Salaun, Bruno
Heineman, Thomas C.
Oostvogels, Lidia
author_sort Vink, Peter
collection PubMed
description BACKGROUND: The adjuvanted recombinant zoster vaccine (RZV) has demonstrated >90% efficacy against herpes zoster in adults ≥50 years of age and 68% efficacy in autologous hematopoietic stem cell transplant recipients ≥18 years of age. We report the immunogenicity and safety of RZV administered to patients with solid tumors (STs) before or at the start of a chemotherapy cycle. METHOD: In this phase 2/3 observer‐blind, multicenter study (NCT01798056), patients with STs who were ≥18 years of age were randomized (1:1) to receive 2 doses of RZV or placebo 1‐2 months apart and stratified (4:1) according to the timing of the first dose with respect to the start of a chemotherapy cycle (first vaccination 8‐30 days before the start or at the start [±1 day] of a chemotherapy cycle). Anti‐glycoprotein E (gE) antibody concentrations, gE‐specific CD4(+) T cell frequencies, and vaccine response rates (VRRs) were assessed 1 month after dose 1 and 1 and 12 months after dose 2. Reactogenicity and safety were assessed in the total vaccinated cohort through 12 months after dose 2. RESULTS: There were 232 participants in the total vaccinated cohort, 185 participants in the according‐to‐protocol cohort for humoral immunogenicity, and 58 participants in the according‐to‐protocol cohort for cell‐mediated immunogenicity. Postvaccination anti‐gE antibody concentrations, gE‐specific CD4(+) T cell frequencies and VRRs were higher in RZV recipients than in placebo recipients. Solicited adverse events (AEs) were more frequent among RZV recipients than placebo recipients. Incidence of unsolicited AEs, serious AEs, fatalities, and potential immune‐mediated diseases were similar between RZV and placebo recipients. CONCLUSION: RZV was immunogenic in patients with STs receiving immunosuppressive chemotherapies. Humoral and cell‐mediated immune responses persisted 1 year after vaccination. No safety concerns were identified.
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spelling pubmed-67668942019-10-01 Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial Vink, Peter Delgado Mingorance, Ignacio Maximiano Alonso, Constanza Rubio‐Viqueira, Belen Jung, Kyung Hae Rodriguez Moreno, Juan Francisco Grande, Enrique Marrupe Gonzalez, David Lowndes, Sarah Puente, Javier Kristeleit, Hartmut Farrugia, David McNeil, Shelly A. Campora, Laura Di Paolo, Emmanuel El Idrissi, Mohamed Godeaux, Olivier López‐Fauqued, Marta Salaun, Bruno Heineman, Thomas C. Oostvogels, Lidia Cancer Original Articles BACKGROUND: The adjuvanted recombinant zoster vaccine (RZV) has demonstrated >90% efficacy against herpes zoster in adults ≥50 years of age and 68% efficacy in autologous hematopoietic stem cell transplant recipients ≥18 years of age. We report the immunogenicity and safety of RZV administered to patients with solid tumors (STs) before or at the start of a chemotherapy cycle. METHOD: In this phase 2/3 observer‐blind, multicenter study (NCT01798056), patients with STs who were ≥18 years of age were randomized (1:1) to receive 2 doses of RZV or placebo 1‐2 months apart and stratified (4:1) according to the timing of the first dose with respect to the start of a chemotherapy cycle (first vaccination 8‐30 days before the start or at the start [±1 day] of a chemotherapy cycle). Anti‐glycoprotein E (gE) antibody concentrations, gE‐specific CD4(+) T cell frequencies, and vaccine response rates (VRRs) were assessed 1 month after dose 1 and 1 and 12 months after dose 2. Reactogenicity and safety were assessed in the total vaccinated cohort through 12 months after dose 2. RESULTS: There were 232 participants in the total vaccinated cohort, 185 participants in the according‐to‐protocol cohort for humoral immunogenicity, and 58 participants in the according‐to‐protocol cohort for cell‐mediated immunogenicity. Postvaccination anti‐gE antibody concentrations, gE‐specific CD4(+) T cell frequencies and VRRs were higher in RZV recipients than in placebo recipients. Solicited adverse events (AEs) were more frequent among RZV recipients than placebo recipients. Incidence of unsolicited AEs, serious AEs, fatalities, and potential immune‐mediated diseases were similar between RZV and placebo recipients. CONCLUSION: RZV was immunogenic in patients with STs receiving immunosuppressive chemotherapies. Humoral and cell‐mediated immune responses persisted 1 year after vaccination. No safety concerns were identified. John Wiley and Sons Inc. 2019-02-01 2019-04-15 /pmc/articles/PMC6766894/ /pubmed/30707761 http://dx.doi.org/10.1002/cncr.31909 Text en © 2019 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Articles
Vink, Peter
Delgado Mingorance, Ignacio
Maximiano Alonso, Constanza
Rubio‐Viqueira, Belen
Jung, Kyung Hae
Rodriguez Moreno, Juan Francisco
Grande, Enrique
Marrupe Gonzalez, David
Lowndes, Sarah
Puente, Javier
Kristeleit, Hartmut
Farrugia, David
McNeil, Shelly A.
Campora, Laura
Di Paolo, Emmanuel
El Idrissi, Mohamed
Godeaux, Olivier
López‐Fauqued, Marta
Salaun, Bruno
Heineman, Thomas C.
Oostvogels, Lidia
Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial
title Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial
title_full Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial
title_fullStr Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial
title_full_unstemmed Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial
title_short Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial
title_sort immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: a randomized trial
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6766894/
https://www.ncbi.nlm.nih.gov/pubmed/30707761
http://dx.doi.org/10.1002/cncr.31909
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