# name
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

# metadata.dc.description.abstract[].value
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).

# metadata.dc.source[].value
Articles publicats en revistes (Medicina)

# metadata.dc.title[].value
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