RT Journal Article
T1 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.
A1 Martinez-Atienza, Juliana
A1 Rosso-Fernández, Clara
A1 Roca, Cristina
A1 Aydillo, Teresa A
A1 Gavaldà, Joan
A1 Moreno, Asunción
A1 Montejo, Jose M
A1 Torre-Cisneros, Julian
A1 Fariñas, M Carmen
A1 Fortun, Jesus
A1 Sabé, Nuria
A1 Muñoz, Patricia
A1 Blanes-Julia, Marino
A1 Suárez-Benjumea, Alejandro
A1 López-Medrano, Francisco
A1 Pérez-Romero, Pilar
A1 Cordero, Elisa
K1 Influenza prevention
K1 Influenza vaccination
K1 Randomized trial
K1 Solid organ transplant
K1 Ensayos clínicos controlados aleatorios como asunto
K1 Protocolos clínicos
K1 Vacunas contra la Influenza
K1 Trasplantes
AB BACKGROUNDDespite 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/DESIGNThis 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.DISCUSSIONThis 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).
PB BioMed Central
YR 2014
FD 2014-08-28
LK http://hdl.handle.net/10668/2743
UL http://hdl.handle.net/10668/2743
LA en
NO Martinez-Atienza J, Rosso-Fernández C, Roca C, Aydillo TA, Gavaldà J, Moreno A, et al. 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. Trials. 2014; 15:338
NO TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT01761435 (registered 13 December 2012). EudraCT Identifier: 2011-003243-21 (registered 4 July 2011).  Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't;
DS RISalud
RD Apr 8, 2025