VZV vaccination to prevent herpes zoster after transplantation - Vaccination to prevent herpes zoster
- Conditions
- Herpes ZosterMedDRA version: 12.0Level: LLTClassification code 10019974Term: Herpes zosterMedDRA version: 12.0Level: LLTClassification code 10036897Term: Prophylactic vaccinationMedDRA version: 12.0Level: LLTClassification code 10023438Term: Kidney transplant
- Registration Number
- EUCTR2009-014268-20-NL
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
- 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 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Use of immunosuppresion (inhalation corticosteroids are allowed)
- Neomycine allergy
- Fever
- Immunodeficiency due to e.g. acute/chronic, lymphoma or HIV
- Active tuberculosis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main 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.;Secondary Objective: none;Primary end point(s): VZV-specific IgG and IgM levels from baseline to endpoint (1 year after vaccination).<br>VZV-specific T-cell reactivity using flow cytometry specific from baseline to endpoint.<br>
- Secondary Outcome Measures
Name Time Method