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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
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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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MARTÍNEZ-ATIENZA, Juliana, 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. Vol. 15, num. 338. ISSN 1745-6215. [consulted: 13 of August of 2026]. Available at: https://hdl.handle.net/2445/68438