More knowledge on immunity to VZV in these patient groups is necessary to be able to design preventive strategies to VZV infections in the future. To reach these goals, the proposed study is divided into two parts. The first part aims to determine…
ID
Source
Brief title
Condition
- Immune disorders NEC
- Viral infectious disorders
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Inter alia, antibody levels to VZV will be determined. For all secundary study
parameters, please see 2.2 of the research protocol (C1).
Background summary
Varicella-zoster virus (VZV) causes varicella (chickenpox) as a primary
infection and herpes zoster (shingles) when reactivating. Patients with chronic
kidney disease, especially patients receiving renal replacement therapy, and
renal transplantation patients are immunocompromised because of their uraemic
state and immunosuppressive therapies, respectively. As a result of the
immunocompromisation in these patients, risk of infections among which
infection with VZV, is increased. The risk of herpes zoster in these patient
groups is estimated to be 3-15 times higher than in the general population. A
primary varicella infection or reactivation causes serious threats in these
immunocompromised patients as even a lethal outcome is possible.
Study objective
More knowledge on immunity to VZV in these patient groups is necessary to be
able to design preventive strategies to VZV infections in the future. To reach
these goals, the proposed study is divided into two parts. The first part aims
to determine both VZV specific cellular and humoral immunity in patients
receiving renal function replacing therapy, patients before and after renal
transplantation and to compare these results to those in healthy controls. In
the second part, the standard procedure of twice vaccinating VZV seronegative
patients awaiting renal transplantation will be utilized to study the effect of
introduction of VZV in this patient group.
Study design
The first part of the study, determining basic VZV specific immunity in
patients receiving renal function replacing therapy and renal transplantation
patients compared to healthy controls, will be an observational study.
The second part of the study, evaluating the effect of VZV vaccination in VZV
seronegative patients awaiting renal transplantation, before and after
transplantation, will be an observational pilot study.
Study burden and risks
The burden and risks associated with participation in this study will be
minimal as blood drawing will be combined with purposes other than this study,
as explained in the ABR-form and research protocol. For the first part of the
study, 40 mL of blood is required from patients receiving renal function
replacing therapy and healthy controls. Peripheral blood mononuclear cells
(PBMC) from before transplantation of recipients of renal allografts partly are
already present in a Biobank. Additional blood post-transplantation will be
requested from these patients at visit of the out-patient clinic.
For the second part of the study, drawing of extra blood (40 mL) will be
required on at least 5 occasions, but up to 10 occasions when a patient is to
receive a renal allograft.
As only a limited amount of extra blood will be drawn at the different time
points, only in exceptional cases an additional puncture will be necessary and
even then the risks of venapuncture are small when executed by experienced
persons, in our opinion the importance of the study outweighs burden associated
with participation
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49283.042.14 |