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Immunological Monitoring of VZV Vaccination in Patients with Renal Failure versus Healthy Individuals.


- candidate number14236
- NTR NumberNTR3825
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jan-2013
- Secondary IDsNL2855700009 CCMO
- Public TitleImmunological Monitoring of VZV Vaccination in Patients with Renal Failure versus Healthy Individuals.
- Scientific TitleImmunological Monitoring of VZV Vaccination in Patients with Renal Failure versus Healthy Individuals.
- ACRONYM
- hypothesisProphylactic 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) studiedRenal insufficiency, Prevention, Renal transplant , Herpes zoster vaccination
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-dec-2012
- planned closingdate1-jan-2014
- Target number of participants80
- InterventionsOne 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 outcome1. 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 [14] 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 outcomeN/A
- TimepointsT = 0 (time of vaccination);
T = 1 month after vaccination;
T = 3 months after vaccination;
T = 1 year after vaccination (endpoint).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. N.M. Besouw, van
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W. Weimar
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summary40 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)
- RECORD25-jan-2013 - 9-feb-2013


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