E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |