Track topics on Twitter Track topics that are important to you
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
The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a ...
Rationale: Oral vaccination is known to induce a systemic immune response as well as an immune response in mucosal tissues, and can therefore serve as a model to study systemic and mucosal...
Ulcerative colitis is a chronic inflammatory bowel disease caused by an imbalance between natural defence mechanisms in the intestinal mucosa and microbes in the intestinal lumen. We hypot...
The purpose of this study is to study on compliance, safety and effectivity of vaccination for children with hematologic malignancies or solid tumors and their parents.
Randomized controlled trial of influenza vaccination versus referral for vaccination in the Emergency department. Is the Emergency Department an effective venue for vaccination for influen...
Introduction: Despite the extraordinary progress made in the field of vaccination, a large number of children in the last decade, 24 million children, or nearly 20% of children born every year, do not...
In the U.S., HPV vaccination has been recommended for females since 2006 and males since 2011. We assessed temporal trends in HPV vaccination (≥1 dose) among 9-26-year-olds in the 2011-2016 NHANES. ...
In many countries, those at risk for complications due to influenza are invited for influenza vaccination, to prevent serious consequences for themselves and those around them. However, vaccination ra...
Influenza vaccination is the best protection against infection and severe complications of disease, such as hospitalization and death. Therefore, it is important to accurately estimate vaccination cov...
Routine prophylactic vaccination and mass vaccination strategies have been used to control both endemic and epidemic disease caused by Neisseria meningitidis globally. This review discusses real-world...
Rate of VACCINATION as defined by GEOGRAPHY and or DEMOGRAPHY.
Group activities directed against VACCINATION.
Refusal to receive VACCINATION.
Administration of a vaccine to large populations in order to elicit IMMUNITY.
The cutaneous and occasional systemic reactions associated with vaccination using smallpox (variola) vaccine.
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...
Chronic kidney disease (CKD), also known as chronic renal disease, is a progressive loss in renal function over a period of months or years. The symptoms of worsening kidney function are non-specific, and might include feeling generally unwell and experi...
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...