Immunity to varicella-zoster virus in immunocompromised renal disease patients
- Conditions
- immunosuppression by chronic renal failure/renal replacement therapy amd renal transplantation transplantation100276651004743810038430
- Registration Number
- NL-OMON45220
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
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
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Pregnancy
* Malignancy (at present or <2 years ago), except for skin malignancies;For patients receiving renal function replacement therapy:
* Underlying auto-immune disorder as cause for need renal function replacement therapy
* Use of immunosuppressive medication other than *7.5 mg prednisolone/day, or immunostimulatory medication
* Less than 3 months duration of renal replacement therapy;For participants receiving VZV vaccination, the second part of the study:
* No administration of VZV vaccine Varivax due to any reason
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study endpoint will be cell-mediated immunity, as assessed by two<br /><br>different methods. The first method is to determine production of interferon-*<br /><br>by T cells in response to VZV stimulation using the enzyme linked immunosorbent<br /><br>spot (ELISpot) assay, expressed as number of spot-forming cells per 2x10^5<br /><br>peripheral blood mononuclear cells. The second method is determining<br /><br>proliferating capacity of CD4+ and CD8+ T cells in response to VZV stimulation<br /><br>using carboxyfluorescein succinimidyl ester (CFSE) dye dilution proliferation<br /><br>assays. Proliferating capacity will be expressed using proliferation indices. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Inter alia, antibody levels to VZV will be determined. For all secundary study<br /><br>parameters, please see 2.2 of the research protocol (C1).</p><br>