Vaccination against cytomegalovirus using own blood cells, a pilot study in patients awaiting kidney transplantatio

• Conditions: Cytomegalovirus infection in patients awaiting kidney transplantation and after kidney transplantation; MedDRA version: 15.1Level: LLTClassification code 10046859Term: VaccinationSystem Organ Class: 100000004865; MedDRA version: 15.1Level: LLTClassification code 10023418Term: Kidney failureSystem Organ Class: 100000004857; MedDRA version: 15.1Level: LLTClassification code 10009703Term: CMV infectionSystem Organ Class: 100000004862; MedDRA version: 15.1Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-005575-13-BE
• Lead Sponsor: Antwerp University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-26
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. ;Secondary Objective: 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. ;Primary end point(s): injection-related toxicities;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)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): obtaining detectable CMV specific cellular immunity<br><br>Additional end points after transplantation: CMV viraemia, need for anti-CMV-treatment;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