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.
Conditions
Interventions
Trade Name: DUKORAL
Product Name: Dukoral
Pharmaceutical Form: Oral suspension
CAS Number: 0
Other descriptive name: VIBRIO CHOLERAE O1 INABA, EL TOR BIOTYPE (FORMALIN INACTIVATED)
Concentration unit:
Sponsors
Leiden University Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. To compare the immunogenicity of inactivated oral cholera vaccine (Dukoral) between renal transplant recipients and healthy controls.;Primary end point(s): Seroconversion rate. 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. | — |
Countries
Netherlands
Outcome results
None listed