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.
ID
Bron
Aandoening
renal insufficiency herpes zoster vaccination prevention renal transplantation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. VZV-specific IgG and IgM levels;<br>
2. Percentage of VZV-reactive memory CD4+ and CD8+ T-cells.<br><br>
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).<br>
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).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
T = 0 (time of vaccination);
T = 1 month after vaccination;
T = 3 months after vaccination;
T = 1 year after vaccination (endpoint).
Onderzoeksproduct en/of interventie
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.
Publiek
postbus 2040
N.M. Besouw, van
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7035419
Wetenschappelijk
postbus 2040
N.M. Besouw, van
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7035419
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3637 |
| NTR-old | NTR3825 |
| CCMO | NL28557.000.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON37984 |