Mucosal Response in Immunocompromised Host (NCT01109914) | Clinical Trial Compass
CompletedPhase 4
Mucosal Response in Immunocompromised Host
Netherlands51 participantsStarted 2010-04
Plain-language summary
The aim of this study is to verify whether vaccination with DukoralĀ® (SBL Vaccines) induces an immune response in renal transplant recipients on prednisolone in combination with either a calcineurin inhibitor CNI) or mycophenolate mofetil (MMF).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
HEALTHY VOLUNTEERS
Inclusion criteria:
* Above 18 years of age
* Informed consent
Exclusion Criteria:
* History of an auto-immune disease (SLE, ANCA associated vasculitis, Goodpasture, Henoch Schonlein, cryoglobulinemia, secondary vasculitis, polyarteritis nodosa and immunodeficiency disorders like IgA deficiency)
* Chronic infection
* Past vaccination with Dukoral or another cholera or ETEC vaccine
* History of infection with Vibrio cholerae
* Episode of diarrhoea in the 6 months prior to inclusion
* Allergy to vaccine-specific components
* History of a severe allergic reaction to any vaccine
* Treatment with blood products in the 3 months prior to inclusion
* Current pregnancy or breastfeeding
* Premenopausal women not willing to use contraceptives during the first 60 days after vaccination
* Use of any immunosuppressive drug
RENAL TRANSPLANT RECIPIENTS
Inclusion Criteria:
* Above 18 years of age
* Creatinin clearance ā„ 40 ml/min measured in the 6 months prior to inclusion
* Stable renal function for 1 year prior to inclusion
* Stable immunosuppressive regimen of a CNI, MMF or mTORi combined with prednisolone for at least 3 months prior to inclusion
* Informed Consent
Exclusion Criteria:
* History of an auto-immune disease (SLE, ANCA associated vasculitis, Goodpasture, Henoch Schonlein, cryoglobulinemia, secondary vasculitis, polyarteritis nodosa and immunodeficiency disorders like IgA deficiency)
* Chronic infection
* Treatment for rejection of the transplant in tā¦
What they're measuring
1
Percentage seroconversion among all renal transplant recipients.