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Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial

BACKGROUND: Despite administration of annual influenza vaccination, influenza-associated complications in transplant recipients continue to be an important cause of hospitalization and death. Although influenza vaccination has been proven to be the most effective measure to reduce influenza infectio...

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Autores principales: Martinez-Atienza, Juliana, Rosso-Fernández, Clara, Roca, Cristina, Aydillo, Teresa A, Gavaldà, Joan, Moreno, Asunción, Montejo, Jose M, Torre-Cisneros, Julian, Fariñas, M Carmen, Fortun, Jesus, Sabé, Nuria, Muñoz, Patricia, Blanes-Julia, Marino, Suárez-Benjumea, Alejandro, López-Medrano, Francisco, Pérez-Romero, Pilar, Cordero, Elisa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4159520/
https://www.ncbi.nlm.nih.gov/pubmed/25168918
http://dx.doi.org/10.1186/1745-6215-15-338
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author Martinez-Atienza, Juliana
Rosso-Fernández, Clara
Roca, Cristina
Aydillo, Teresa A
Gavaldà, Joan
Moreno, Asunción
Montejo, Jose M
Torre-Cisneros, Julian
Fariñas, M Carmen
Fortun, Jesus
Sabé, Nuria
Muñoz, Patricia
Blanes-Julia, Marino
Suárez-Benjumea, Alejandro
López-Medrano, Francisco
Pérez-Romero, Pilar
Cordero, Elisa
author_facet Martinez-Atienza, Juliana
Rosso-Fernández, Clara
Roca, Cristina
Aydillo, Teresa A
Gavaldà, Joan
Moreno, Asunción
Montejo, Jose M
Torre-Cisneros, Julian
Fariñas, M Carmen
Fortun, Jesus
Sabé, Nuria
Muñoz, Patricia
Blanes-Julia, Marino
Suárez-Benjumea, Alejandro
López-Medrano, Francisco
Pérez-Romero, Pilar
Cordero, Elisa
author_sort Martinez-Atienza, Juliana
collection PubMed
description BACKGROUND: Despite administration of annual influenza vaccination, influenza-associated complications in transplant recipients continue to be an important cause of hospitalization and death. Although influenza vaccination has been proven to be the most effective measure to reduce influenza infection after transplantation, transplant recipients are still vulnerable to influenza infections, with lower serological responses to vaccination compared to the general population. In order to assess the efficacy and safety of an alternative immunization scheme for solid organ transplant recipients, the TRANSGRIPE1-2 Study Group aimed to test a booster dose administration 5 weeks after the standard vaccination. The primary objective of this trial was to compare short-term and long-term neutralizing antibody immunogenicity of a booster dose of influenza vaccination to the standard single-dose immunization scheme. Secondary objectives included the evaluation of the efficacy and/or safety, cellular immune response, incidence of influenza infection, graft rejection, retransplant and mortality rates. METHODS/DESIGN: This phase III, randomized, controlled, open-label clinical trial was conducted between October 2012 and December 2013 in 12 Spanish public referral hospitals. Solid organ transplant recipients (liver, kidney, heart or lung), older than 16 years of age more than 30 days after transplantation were eligible to participate. Patients (N = 514) were stratified 1:1 by center, type of organ and time after transplantation and who either received the standard single dose (n = 257) or were treated according to a novel influenza vaccination schedule comprising the administration of a booster dose 5 weeks after standard vaccination (n = 254). Seroconversion rates were measured as a determinant of protection against influenza (main outcome). Efficacy and safety outcomes were followed until 1 year after influenza vaccination with assessment of short-term (0, 5, 10 and 15 weeks) and long-term (12 months) results. Intention-to-treat, per-protocol and safety analyses will be performed. DISCUSSION: This trial will increase knowledge about the safety and efficacy of a booster dose of influenza vaccine in solid organ transplant recipients. At the time the manuscript was submitted for publication, trial recruitment was closed with a total of 499 participants included during a 2-month period (within the seasonal influenza vaccination campaign). TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01761435 (registered 13 December 2012). EudraCT Identifier: 2011-003243-21 (registered 4 July 2011).
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spelling pubmed-41595202014-09-11 Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial Martinez-Atienza, Juliana Rosso-Fernández, Clara Roca, Cristina Aydillo, Teresa A Gavaldà, Joan Moreno, Asunción Montejo, Jose M Torre-Cisneros, Julian Fariñas, M Carmen Fortun, Jesus Sabé, Nuria Muñoz, Patricia Blanes-Julia, Marino Suárez-Benjumea, Alejandro López-Medrano, Francisco Pérez-Romero, Pilar Cordero, Elisa Trials Study Protocol BACKGROUND: Despite administration of annual influenza vaccination, influenza-associated complications in transplant recipients continue to be an important cause of hospitalization and death. Although influenza vaccination has been proven to be the most effective measure to reduce influenza infection after transplantation, transplant recipients are still vulnerable to influenza infections, with lower serological responses to vaccination compared to the general population. In order to assess the efficacy and safety of an alternative immunization scheme for solid organ transplant recipients, the TRANSGRIPE1-2 Study Group aimed to test a booster dose administration 5 weeks after the standard vaccination. The primary objective of this trial was to compare short-term and long-term neutralizing antibody immunogenicity of a booster dose of influenza vaccination to the standard single-dose immunization scheme. Secondary objectives included the evaluation of the efficacy and/or safety, cellular immune response, incidence of influenza infection, graft rejection, retransplant and mortality rates. METHODS/DESIGN: This phase III, randomized, controlled, open-label clinical trial was conducted between October 2012 and December 2013 in 12 Spanish public referral hospitals. Solid organ transplant recipients (liver, kidney, heart or lung), older than 16 years of age more than 30 days after transplantation were eligible to participate. Patients (N = 514) were stratified 1:1 by center, type of organ and time after transplantation and who either received the standard single dose (n = 257) or were treated according to a novel influenza vaccination schedule comprising the administration of a booster dose 5 weeks after standard vaccination (n = 254). Seroconversion rates were measured as a determinant of protection against influenza (main outcome). Efficacy and safety outcomes were followed until 1 year after influenza vaccination with assessment of short-term (0, 5, 10 and 15 weeks) and long-term (12 months) results. Intention-to-treat, per-protocol and safety analyses will be performed. DISCUSSION: This trial will increase knowledge about the safety and efficacy of a booster dose of influenza vaccine in solid organ transplant recipients. At the time the manuscript was submitted for publication, trial recruitment was closed with a total of 499 participants included during a 2-month period (within the seasonal influenza vaccination campaign). TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01761435 (registered 13 December 2012). EudraCT Identifier: 2011-003243-21 (registered 4 July 2011). BioMed Central 2014-08-28 /pmc/articles/PMC4159520/ /pubmed/25168918 http://dx.doi.org/10.1186/1745-6215-15-338 Text en © Martinez-Atienza et al.; licensee BioMed Central Ltd. 2014 This article is published under license to BioMed Central Ltd. 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 use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Martinez-Atienza, Juliana
Rosso-Fernández, Clara
Roca, Cristina
Aydillo, Teresa A
Gavaldà, Joan
Moreno, Asunción
Montejo, Jose M
Torre-Cisneros, Julian
Fariñas, M Carmen
Fortun, Jesus
Sabé, Nuria
Muñoz, Patricia
Blanes-Julia, Marino
Suárez-Benjumea, Alejandro
López-Medrano, Francisco
Pérez-Romero, Pilar
Cordero, Elisa
Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial
title Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial
title_full Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial
title_fullStr Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial
title_full_unstemmed Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial
title_short Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial
title_sort efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, transgripe 1-2: study protocol for a multicenter, randomized, controlled clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4159520/
https://www.ncbi.nlm.nih.gov/pubmed/25168918
http://dx.doi.org/10.1186/1745-6215-15-338
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