4 research outputs found
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 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)
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 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)
Impact of late presentation of HIV infection on short-, mid- and long-term mortality and causes of death in a multicenter national cohort : 2004-2013
To analyze the impact of late presentation (LP) on overall mortality and causes of death and describe LP trends and risk factors (2004-2013). Cox models and logistic regression were used to analyze data from a nation-wide cohort in Spain. LP is defined as being diagnosed when CD4 < 350 cells/ml or AIDS. Of 7165 new HIV diagnoses, 46.9% (CI:45.7-48.0) were LP, 240 patients died.First-year mortality was the highest (aHR = 10.3[CI:5.5-19.3]); between 1 and 4 years post-diagnosis, aHR = 1.9(1.2-3.0); an
Prediction of long-term outcomes of HIV-infected patients developing non-AIDS events using a multistate approach
Outcomes of people living with HIV (PLWH) developing non-AIDS events (NAEs) remain poorly defined. We aimed to classify NAEs according to severity, and to describe clinical outcomes and prognostic factors after NAE occurrence using data from CoRIS, a large Spanish HIV cohort from 2004 to 2013. Prospective multicenter cohort study. Using a multistate approach we estimated 3 transition probabilities: from alive and NAE-free to alive and NAE-experienced ("NAE development"); from alive and NAE-experienced to death ("Death after NAE"); and from alive and NAE-free to death ("Death without NAE"). We analyzed the effect of different covariates, including demographic, immunologic and virologic data, on death or NAE development, based on estimates of hazard ratios (HR). We focused on the transition "Death after NAE". 8,789 PLWH were followed-up until death, cohort censoring or loss to follow-up. 792 first incident NAEs occurred in 9.01% PLWH (incidence rate 28.76; 95% confidence interval [CI], 26.80-30.84, per 1000 patient-years). 112 (14.14%) NAE-experienced PLWH and 240 (2.73%) NAE-free PLWH died. Adjusted HR for the transition "Death after NAE" was 12.1 (95%CI, 4.90-29.89). There was a graded increase in the adjusted HRs for mortality according to NAE severity category: HR (95%CI), 4.02 (2.45-6.57) for intermediate-severity; and 9.85 (5.45-17.81) for serious NAEs compared to low-severity NAEs. Male sex (HR 2.04; 95% CI, 1.11-3.84), ag