Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza Vaccination

Fundación Pública Andaluza Progreso y Salud499 enrolled

Overview

Randomized, multicenter, open label trial to compare safety and efficacy of two doses stationary flu vaccination vs one doses in Solid Organ Transplant Recipients.

The purposes of this study are: 1. Evaluate the efficacy and safety of a double dose of seasonal flu vaccine compared to a single dose. 2. Determine the specific cellular immune response produced after the first and second vaccine doses of seasonal flu vaccine by in vitro stimulation of specific memory cells (A and B flu viruses). 3. Evaluate the humoral immune response produced after one dose vs two doses of seasonal flu vaccine by the measure of serum antibody levels. 4. Evaluate clinical efficacy of stationary flu vaccine in solid organ transplant recipients. 5. Evaluate a long term cellular and humoral response(1 year) of seasonal flu vaccine. 6. Characterize the genetic expression profile of immune response after the flu vaccine in solid organ transplant recipients by means of a genetic sub-study. 7. Characterize the flu vaccine effect (one dose and two doses) through the antibody anti-HLA(human leukocyte antigen), and its influence on the rejection rate in solid organ transplant recipients, by means of immunologic sub-study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

499

Conditions

Infection in Solid Organ Transplant Recipients

Interventions

Influenza vaccineBIOLOGICAL

Patients will be randomized at 1:1 rate and open label fashion, according to centers, and time elapsed since transplant and type of organ transplanted to one of this two interventions : A arm (usual treatment): Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline. B arm (experimental branch): Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline and 5 weeks after the first dose. The follow-up of both arms will be at 5, 10 and 15 weeks and one year after the baseline.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Solid organ transplant recipient. 2. 16 years or older. 3. More than 30 days after transplantation. 4. Negative pregnancy test for women of childbearing potential 5. The patient must give informed consent Exclusion Criteria: 1. No written informed consent. 2. Acute rejection within 15 days prior to vaccination. 3. Pregnancy. 4. Hypersensitivity to the active substance, any of the excipients and waste, for example: eggs, egg albumin, chicken proteins. 5. History of a previous serious reaction to immunization (eg Guillain-Barré syndrome).

Locations (12)

Hospital Clinic Provincial de Barcelona

Barcelona, Barcelona, Spain

Hospital Universitario de Bellvitge

Barcelona, Barcelona, Spain

Hospital Universitario de Cruces

Bilbao, Bilbao, Spain

Outcomes

Primary Outcomes

Seroconversion rates

Difference in seroconversion rates in both treatment groups at 5, 10, 15 weeks, and 12 months after the first vaccine dose (percent of patients with 4 x increase in the pre-vaccination titers).

Time frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose

Secondary Outcomes

Postvaccination antibody titers

Geometric average postvaccination antibody titers and rate of increase between pre-and post-vaccination geometric mean, post-vaccination seroprotection rate (or percentage of individuals with a titer 1 / 40 as measured by RIH).

Time frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose.

Safety.

Occurrence of grade 3 or 4 toxicity, death, hospitalization, retransplantation, acute rejection and chronic rejection

Time frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose

Efficacy

Detection of clinical cases of influenza following immunization. Nasal swabs to confirm infection with influenza virus by RT-PCR (Reverse transcription polymerase chain reaction).

Time frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose

Antibody anti-HLA

Characterize the flu vaccine effect (one dose and two doses) through the antibody anti-HLA levels, ant its influence on the rejection rate in solid organ transplant recipients, by means of immunologic sub-study.

Time frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose

Cellular response

Determination of the T cells specific immune response measured by production of INFg, IL-2 and IL-4 in the cytoplasm of CD4+ and CD8 + (mononuclear cells) specific for influenza virus by direct immunofluorescence and flow cytometry analysis.

Data from ClinicalTrials.gov

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