Immune respons after inactivated oral cholera vaccination (Dukoral) in kidneytransplant recipients. Mucosal immune response in ImmunoCompromised Host (MICH)
- Conditions
- ETEC-diarrhoeatravelers diarrhoea10017966
- Registration Number
- NL-OMON35457
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
- 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
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method