Immunity to varicella-zoster virus in immunocompromised renal disease patients

Immunity to varicella-zoster virus in immunocompromised renal disease patients - Immunity to VZV in renal disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45220

Enrollment

210

Registered

2014-10-03

Start date

2014-11-25

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

immunosuppression by chronic renal failure/renal replacement therapy amd renal transplantation transplantation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a patient must meet all of the following criteria: * Provision of written informed consent * *18 years of age * For the first part of the study, dependent on which group the participant is included in: o Receiving renal replacement therapy *1 time per week, or o Presence of stored blood samples before and after kidney transplantation in existing Biobank * For the second part of the study: VZV seronegativity o Subject is a VZV seronegative pre-renal transplantation patient and o Intended administration of VZV vaccine Provarivax;For healthy controls, the following criteria must be met: * Provision of written informed consent * *18 years of age

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Pregnancy * Malignancy (at present or

Design outcomes

Primary

Measure	Time frame
Main study endpoint will be cell-mediated immunity, as assessed by two different methods. The first method is to determine production of interferon-* by T cells in response to VZV stimulation using the enzyme linked immunosorbent spot (ELISpot) assay, expressed as number of spot-forming cells per 2x10^5 peripheral blood mononuclear cells. The second method is determining proliferating capacity of CD4+ and CD8+ T cells in response to VZV stimulation using carboxyfluorescein succinimidyl ester (CFSE) dye dilution proliferation assays. Proliferating capacity will be expressed using proliferation indices.	—

Measure

Time frame

Main study endpoint will be cell-mediated immunity, as assessed by two different methods. The first method is to determine production of interferon-* by T cells in response to VZV stimulation using the enzyme linked immunosorbent spot (ELISpot) assay, expressed as number of spot-forming cells per 2x10^5 peripheral blood mononuclear cells. The second method is determining proliferating capacity of CD4+ and CD8+ T cells in response to VZV stimulation using carboxyfluorescein succinimidyl ester (CFSE) dye dilution proliferation assays. Proliferating capacity will be expressed using proliferation indices.

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Secondary

Measure	Time frame
Inter alia, antibody levels to VZV will be determined. For all secundary study parameters, please see 2.2 of the research protocol (C1).	—

Countries

Netherlands

Outcome results