To study if there is a role for prophylactic VZV vaccination prior to transplantation to boost the patients B- and T-cell repertoire and thereby reducing the incidence and morbidity associated with herpes zoster.
ID
Source
Brief title
Condition
- Viral infectious disorders
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
VZV-specific IgG and IgM levels from baseline to endpoint (1 year after
vaccination)
Percentage of VZV-reactive memory CD4+ and CD8+ T-cells from baseline to
endpoint
Secondary outcome
Detection of VZV positive PCR in blood, transplantation will be delayed until
PCR is negative
Background summary
Primary infection with varicella zoster virus (VZV) results in lifelong latent
infection of neurons in sensory ganglia from which it may reactivate, resulting
in herpes zoster. Herpes zoster is a frequent complication after organ
transplantation.
Recently we demonstrated that VZV-specific IgG titres were significantly lower
after transplantation compared to prior to transplantation. Questioned is if
VZV vaccination in patients prior to renal transplantation gives a similar
immunerespons compared with their healthy donors.
Study objective
To study if there is a role for prophylactic VZV vaccination prior to
transplantation to boost the patients B- and T-cell repertoire and thereby
reducing the incidence and morbidity associated with herpes zoster.
Study design
A single centre, open study in patients on waitlist for living renal
transplantation and their living donors.
Intervention
Vaccination with VZV strain to prevent herpes zoster
Study burden and risks
Possible side effects of the vaccination include redness, pain, itching,
swelling, warmth or bruising at the injection site, as well as headache.
At study baseline the research nurse will fill in a questionnaire together with
the patient.
Blood samples will be collected simultaneously with standard clinical
evaluations and usual recurring blood tests following renal transplantation.
Two additional blood tests will be performed compared with standard treatment.
Postbus 2040
Rotterdam 3000 CA
NL
Postbus 2040
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
- Age of patient and donor is 50 years or older
- Patients on waitinglist for living-related kidney transplantation and their donors
- Patients at least 1 month prior to kidney transplantation
- Patient is VZV seropositive before vaccination
- Patient is capable of understanding the purpose and risks of the study, fully informed and given written informed consent
Exclusion criteria
- Use of immunosuppresion (inhalation corticosteroids are allowed)
- Neomycine allergy
- Fever
- Immunodeficiency due to e.g. acute/chronic leukaemia, lymphoma or HIV
- Active tuberculosis
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-014268-20-NL |
| CCMO | NL28557.000.09 |
| OMON | NL-OMON25608 |