Infection in Solid Organ Transplant Recipients Clinical Trial
Official title:
Randomized, Comparative and Prospective Clinical Trial Evaluating Efficacy and Safety of a Dose of Seasonal Flu Vaccine Compared to Two Doses of Vaccine for Prevention of Influenza in Solid Organ Transplant Recipients
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02260596 -
Respiratory Viral Infections in Pediatric Transplantation
|
N/A | |
| Completed |
NCT04637321 -
The Incidence and Risk Factors for Clostridioides Difficle Infection in Solid Organ Transplant Recipients
|
||
| Completed |
NCT02382211 -
T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays
|
||
| Terminated |
NCT01761201 -
"Efficacy and Safety of Levofloxacin vs Isoniazid in Latent Tuberculosis Infection in Liver Transplant Patients".
|
Phase 3 | |
| Recruiting |
NCT05626530 -
Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients
|
Phase 4 | |
| Active, not recruiting |
NCT01527591 -
Pneumococcal Conjugate Vaccine 13 (Prevnar13®) in Children Who Are Solid Organ Transplant Recipients (SOT)
|
N/A | |
| Recruiting |
NCT02503982 -
Valganciclovir Dosing in Pediatric Solid Organ Transplant Recipients
|
Phase 4 | |
| Completed |
NCT01446445 -
Individualization of Ganciclovir and Valganciclovir Doses Using Bayesian Prediction in Renal Transplant Patients.
|
Phase 4 | |
| Completed |
NCT01833416 -
Natural History of Cytomegalovirus (CMV) Infection and Disease Among Renal Transplant Recipients
|
N/A | |
| Completed |
NCT01558037 -
Cell Mediated Immunity With Risk of Cytomegalovirus (CMV) in Solid Organ Transplant Recipients
|
N/A |