E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cytomegalovirus infection in patients awaiting kidney transplantation and after kidney transplantation |
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E.1.1.1 | Medical condition in easily understood language |
Cytomegalovirus infection in patients awaiting kidney transplantation and after kidney transplantation |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046859 |
E.1.2 | Term | Vaccination |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023418 |
E.1.2 | Term | Kidney failure |
E.1.2 | System Organ Class | 100000004857 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009703 |
E.1.2 | Term | CMV infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023438 |
E.1.2 | Term | Kidney transplant |
E.1.2 | System Organ Class | 100000004865 |
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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 |
The primary objective of this pilot study is to evaluate the safety and feasibility of intrader-mal vaccination with RNA-modified autologous dendritic cells (DC), engineered to express the CMV protein pp65, in CMV-seronegative patients awaiting kidney transplantation. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this pilot study is to evaluate the anti-CMV immunity resulting from intradermal vaccination in CMV-seronegative patients awaiting kidney transplantation. After transplantation, CMV-viraemia and the need for anti-CMV treatment will be evaluated. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Adults awaiting kidney transplantation
•Age: ≥ 18 years
•CMV-seronegative, defined as both IgG and IgM = 0
•Negative CMV screening
•Written informed consent
•Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures
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E.4 | Principal exclusion criteria |
•Difficult venous access
•Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
•Patients receiving medication (or other treatment) with an immunomodulating effect in a period of 100 days before the first DC vaccination and during the first year after the first DC vaccination. This includes oral, nasal or inhaled corticosteroids. Topical steroids are permitted but not on the vaccination site. Other vaccinations are not permitted, except for influenza vaccination.
•History or evidence of autoimmune disease
•Impaired immune responsiveness (of any cause) eg. genetic syndromes, hypoglobuli-nemias, chemotherapy in the last 3 months
•HIV-seropositive patients
•Any clinical laboratory abnormality deemed by the investigator to indicate significant undiagnosed illness
•History or evidence of a physician-diagnosed chronic of recurrent inflammatory skin disease at the proposed site(s) of vaccination or DTH skin test in the past 5 years
•Any evidence of damaged skin, moles, scars, tattoos or marks at the proposed actua-tion site(s) that might interfere with the interpretation of local skin reactions
•Patients who received blood products (except albumin) in the previous 60 days
•Pregnancy
•Patients awaiting multiple organ transplantation
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E.5 End points |
E.5.1 | Primary end point(s) |
injection-related toxicities |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Injection-related toxicities: after every vaccination (day 0, week 2,4,6,14,22,30,38,46,54) |
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E.5.2 | Secondary end point(s) |
obtaining detectable CMV specific cellular immunity
Additional end points after transplantation: CMV viraemia, need for anti-CMV-treatment |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
CMV-specific cellular immunity: prior to (D0) and after administration of the dendritic cell vaccine (week 8, week 54, yearly onwards until transplantation, at day 0 of transplantation, at week 12 after transplantation |
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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 | Yes |
E.6.5 | Efficacy | Yes |
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 |
immune response after vaccination |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
First administration in chronic kidney disease patients |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | No |
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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3 months after kidney transplantation of the last study subject |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |