Immune respons after inactivated oral cholera vaccin (Dukoral) in renal transplant recipientsMucosal response in ImmunoCompromised Host (MICH) - MICH
- Conditions
- Single centre, interventional, non-parallel-group trial. Aim: To assess the immunogenicity of inactivated oral cholera vaccine (Dukoral) in renal transplant recipients and healthy controls.
- Registration Number
- EUCTR2010-018377-38-NL
- Lead Sponsor
- eiden University Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- Age = 18 years
- Creatinin clearance = 40 ml/min
- Stable renal function for 1 year prior to inclusion
- Stabe immunosuppressive medication for 3 months prior to inclusion, consisting of prednisone in combination with either a calcineurine inhibitor, mycophenolate mofetil or an mTOR inhibitor
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- A chronic disease which may influence the immune system, other than the renal transplant and accompanying immunosupressive medication
- Chronic infection
- Treatment for graft rejection in the year prior to inclusion
- Prior vaccination with Dukoral or another oral cholera or ETEC vaccine.
- Prior Vibrio cholerae infection
- Travellers' diarrhea 6 months prior to inclusion
- Known allergy to the vaccine or to one of the vaccine components
- History of an anaphylactic reaction following vaccination
- Treatment with plasma or blood products in the 3 months prior to inclusion
- Pregnancy or breast feeding
- Immunosuppressive medication other than prednisone, a calcineurine inhibitor, mycophenolate mofetil or an mTOR inhibitor
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the immunogenicity of inactivated oral cholera vaccine (Dukoral) in renal transplant recipients who use prednisone in combination with either a calcineurin inhibitor, or mycophenolate mofetil or an mTOR-inhibitor.;Secondary Objective: To compare the between-group differences in the immunogenicity of inactivated oral cholera vaccine (Dukoral) in renal transplant recipients who use prednison in combination with either a calcineurin inhibitor, or mycophenolate mofetil or an mTOR-inhibitor.<br><br>To compare the immunogenicity of inactivated oral cholera vaccine (Dukoral) between renal transplant recipients and healthy controls.;Primary end point(s): Seroconversion rate.<br>Seroconversion is defined as a =2-fold rise in the anti-rCTB IgA en IgG titer at day 28. measured using an Enzyme Immuno Assay (EIA) or a =2-fold rise in th number of IgA- or IgG secreting peripheral blood lymphocytes (PBMC), with an obligatiry minimum of 10 per 10 million PBMC.
- Secondary Outcome Measures
Name Time Method