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The aim of this study is to verify whether vaccination with Dukoral® (SBL Vaccines) induces an immune response in renal transplant recipients on prednisolone in combination with either a calcineurin inhibitor CNI), mycophenolate mofetil (MMF) or an mTOR inhibitor (mTORi).
LT-ETEC is the most common cause of travelers' diarrhoea. Dukoral® (SBL Vaccines) reduces the severity and duration of LT-ETEC induced diarrhea. Dehydration due to diarrhea poses a risk to the health of renal transplant recipients. Therefore Dukoral may benefit this group of travelers.
AIM OF THIS STUDY:
Primary objective: To verify whether vaccination with Dukoral® (SBL Vaccines) induces an immune response in renal transplant recipients on prednisolone in combination with either a calcineurin inhibitor (cyclosporine or tacrolimus), mycophenolate mofetil or an mTOR inhibitor (sirolimus or everolimus).
Secondary objective: To evaluate to what extent, the immune response differs, depending on the use of different classes of immunosuppressive drugs (CNI, MMF or mTORi).
Single center interventional study.
Population: The population base of the study consists of adult renal transplant recipients who received their transplant at our medical center. The control population consists of the healthy partners and siblings of the renal transplant recipients. We intend to include 10 healthy volunteers and 60 renal transplant recipients (20 on prednisolone and a CNI, 20 on prednisolone and MMF and 20 on prednisolone and an mTORi.
Intervention: Dukoral® (SBL Vaccines) will be administered orally at baseline (day 0) and at day 14.
Laboratory analysis: Serum, peripheral blood mononuclear cells (PBMCs) and saliva is collected before the first vaccination (day 0) and at day 21. IgA and IgG in serum- and saliva is measured using Enzyme Immunoassay (EIA). The number of PMBCs that secrete IgA- or IgG upon stimulation with cholera toxin is measured using B-cell Enzyme-Linked Immunospot (ELISPOT). The analysis is performed at Leiden University Medical Center.
Statistical analysis: No formal sample-size calculation was performed. The crude outcome estimates will be adjusted for variables that may influence the outcome (age, time after transplantation, past treatment for transplant rejection, current renal function, cumulative prednisolone dose, serum concentration (i.e. area under the curve) of CNI, MMF and mTORi.
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Leiden Univeristy Medical Centre
Leiden University Medical Center
Published on BioPortfolio: 2014-08-27T03:14:12-0400
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