Development of Varicella-zoster virus (VZV)-specific CD4+ T cells on primary VZV infection or vaccination in renal transplant (RTX) recipients and healthy donors - VZV-specific CD4+ T cells
- Conditions
- Patients (aged 24 months to 80 years) listed for renal transplantation
- Registration Number
- EUCTR2008-007235-40-AT
- Lead Sponsor
- Department für Pädiatrie, Medizinische Universität Innsbruck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
Patients listed for renal transplantation:
Patients with renal failure (meeting the criterias for transplantion listing; renal failure stage 4 or 5, glomerular filtration rate < 29ml/min/1.73m2); age 24 months to 80 years; routine VZV vaccination (Varivax)
Healthy subjects (according to WHO definition): age 24 months to 80 years; routine VZV vaccination with Varivax
Are the trial subjects under 18? yes
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
Patients listed for renal transplantation:
Positive VZV IgG antibody levels at time point 0; immunosuppression at time of vaccinations; malignancies; rheumatic diseases; loss of immunoglobulins; proteinuria; blood transfusion or treatment with intravenous immunglobulin or plasma products in the last 6 months; pregnancy (validated by urine beta-HCG)
Healthy subjects: Positive VZV IgG antibody levels at time point 0; malignancies; rheumatic diseases; immunosuppression; cortisone therapy in the last 6 months; cytostatic therapy; blood transfusion or treatment with intravenous immunglobulin or plasma products in the last 6 months; pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method