@article{10902/31320,
year = {2014},
url = {https://hdl.handle.net/10902/31320},
abstract = {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).},
organization = {This study was funded by a research grant for the promotion of investigator-driven clinical research from the Ministry of Health, Social Policy and Equity of the Spanish Government (project number EC11-456). We are also thankful to the Andalusian Progreso y Salud Public Foundation for assuming the roles and responsibilities of sponsoring this clinical trial. The Spanish Network Research in Infectious Diseases supported the development of the trial. We are grateful to the Andalusian Health Service for granting the IMP for the trial. We also thank the sponsor of the trial for providing administrative support for the project when necessary. We would also like to acknowledge the support of all the people involved in the trial, the clinical teams at the participating sites, the investigators, the patients, the management and coordination teams, and the clinical trial monitors.},
publisher = {BioMed Central},
publisher = {Trials, 2014, 15(1), 338},
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.},
author = {Martinez-Atienza, Juliana and Rosso-Fernández, Clara and Roca, Cristina and Aydillo, Teresa A. and Gavaldà, Joan and Moreno, Asunción and Montejo, José M. and Torre-Cisneros, Julián and Fariñas Álvarez, María del Carmen and Fortun, Jesús and Sabé, Nuria and Muñoz, Patricia and Blanes-Julia, Marino and Suárez-Benjumea, Alejandro and López-Medrano, Francisco and Pérez-Romero, Pilar and Cordero, Elisa},
}