Infection in Solid Organ Transplant Recipients
Conditions
Keywords
Influenza, Solid Organ Transplant Recipients
Brief summary
Randomized, multicenter, open label trial to compare safety and efficacy of two doses stationary flu vaccination vs one doses in Solid Organ Transplant Recipients.
Detailed description
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.
Interventions
BIOLOGICALInfluenza vaccine
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.
Sponsors
Spanish Network for Research in Infectious Diseases
Fundación Pública Andaluza Progreso y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rates | At 5, 10, 15 weeks, and 12 months after the first vaccine dose | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety. | At 5, 10, 15 weeks, and 12 months after the first vaccine dose | Occurrence of grade 3 or 4 toxicity, death, hospitalization, retransplantation, acute rejection and chronic rejection |
| Efficacy | At 5, 10, 15 weeks, and 12 months after the first vaccine dose | Detection of clinical cases of influenza following immunization. Nasal swabs to confirm infection with influenza virus by RT-PCR (Reverse transcription polymerase chain reaction). |
| Postvaccination antibody titers | At 5, 10, 15 weeks, and 12 months after the first vaccine dose. | 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). |
| Cellular response | At 5, 10, 15 weeks, and 12 months after the first vaccine dose | 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. |
| Clinical complications | At 5, 10, 15 weeks, and 12 months after the first vaccine dose | Clinical severity (hospitalization, ICU admission, death, rejection). Time to clinical stability will be register. |
| Antibody anti-HLA | At 5, 10, 15 weeks, and 12 months after the first vaccine dose | 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. |
Countries
Spain
Outcome results
None listed