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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-007235-40-AT

Enrollment

180

Registered

2009-03-30

Start date

2009-06-10

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients (aged 24 months to 80 years) listed for renal transplantation

Interventions

Trade Name: Varivax Product Name: Varivax Product Code: 2-00300 Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients listed for renal transplantation: Patients with renal failure (meeting the criterias for transplantion listing; renal failure stage 4 or 5, glomerular filtration rate =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The proposed study is aimed to investigate the kinetics and maintenance of CD4+ T cell memory by evaluating VZV-specific CD4+ T cells after two-dose VZV vaccination in RTX recipients compared to two control groups of healthy age-matched children after VZV wildtype infection or after VZV vaccination, prospectively. Additionally, VZV IgG antibody levels and IgG avidity are monitored over 18 months in RTX recipients and healthy age-matched controls to assess humoral immunity against VZV. Main objective: percentage of VZV-specific CD4+ T cells;Secondary Objective: VZV-specific IgG antibodies (U/ml) and relative avidity index of VZV-specific IgG antibodies;Primary end point(s): Drop-out criteria for vaccination: Transplantation, immunosuppression, wish of patient, wish of doctor Drop-out criteria for blood withdrawal: wish of patient, wish of doctor	—

Measure

Time frame

Main Objective: The proposed study is aimed to investigate the kinetics and maintenance of CD4+ T cell memory by evaluating VZV-specific CD4+ T cells after two-dose VZV vaccination in RTX recipients compared to two control groups of healthy age-matched children after VZV wildtype infection or after VZV vaccination, prospectively. Additionally, VZV IgG antibody levels and IgG avidity are monitored over 18 months in RTX recipients and healthy age-matched controls to assess humoral immunity against VZV. Main objective: percentage of VZV-specific CD4+ T cells;Secondary Objective: VZV-specific IgG antibodies (U/ml) and relative avidity index of VZV-specific IgG antibodies;Primary end point(s): Drop-out criteria for vaccination: Transplantation, immunosuppression, wish of patient, wish of doctor Drop-out criteria for blood withdrawal: wish of patient, wish of doctor

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026