|- candidate number||14236|
|- NTR Number||NTR3825|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-jan-2013|
|- Secondary IDs||NL2855700009 CCMO|
|- Public Title||Immunological Monitoring of VZV Vaccination in Patients with Renal Failure versus Healthy Individuals.|
|- Scientific Title||Immunological Monitoring of VZV Vaccination in Patients with Renal Failure versus Healthy Individuals.|
|- hypothesis||Prophylactic VZV vaccination before transplantation to boost the patient's memory T and B-cell repertoire and thereby reduce the morbidity associated with herpes zoster after transplantation.|
|- Healt Condition(s) or Problem(s) studied||Renal insufficiency, Prevention, Renal transplant , Herpes zoster vaccination|
|- Inclusion criteria||1. Age ≥ 50 years;|
2. Patients on waitlist for living-related kidney transplantation and their donors;
3. Patients at least 1 month prior to kidney transplantation;
4. VZV seropositive before vaccination;
5. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained).
|- Exclusion criteria||1. Use of immunosuppression (inhalation of corticosteroids is allowed);|
2. Neomycine allergy;
3. Fever (inclusion: one week no fever);
4. Immunodeficiency due to e.g. acute or chronic leukaemia, lymphoma or HIV;
5. Active tuberculosis.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-dec-2012|
|- planned closingdate||1-jan-2014|
|- Target number of participants||80|
|- Interventions||One vaccination with Zostavax, subcutaneous. Blood-samples at time T = 0, T = 1 month after vaccination, T = 3 months after vaccination, T = 1 year after vaccination.|
|- Primary outcome||1. VZV-specific IgG and IgM levels;|
2. Percentage of VZV-reactive memory CD4+ and CD8+ T-cells.
CD3+ and CD14+ will be isolated from the peripheral blood cells to determine the percentage of VZV-specific CD4+ and CD8+ T-cells by flowcytometry  at the Transplantation Laboratory (7 tubes of 6 ml heparinized blood).
Four samples of blood will be sampled from a vein in the forearm by venapunction by our nurses at day of inclusion (day 0), 1, 3 and 12 months after vaccination. At day 0 and 3 months VZV-specific titres and T-cell reactivity will be performed (8 tubes each time: 48 ml), and 1 and 12 months after vaccination VZV-specific titres and VZV-PCR will be performed (2 tubes: 12 ml).
|- Secondary outcome||N/A|
|- Timepoints||T = 0 (time of vaccination);|
T = 1 month after vaccination;
T = 3 months after vaccination;
T = 1 year after vaccination (endpoint).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. N.M. Besouw, van|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. W. Weimar|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary||40 patients with renal insufficieny (age 50+) on the waitlist for renal transplantation, who are VZV IgG-positive will be vaccinated once with Zostavax, to booster their immune-respons. 40 healthy controls will be donors for living renal transplantation, over the age of 50, who are VZV IgG positive. Both groups will be compared whether they have comparible immune-responses and rise in VZV-specific titres. |
|- Main changes (audit trail)|
|- RECORD||25-jan-2013 - 9-feb-2013|