VZV vaccination to prevent herpes zoster after transplantation - Vaccination to prevent herpes zoster

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014268-20-NL

Enrollment

Registered

2009-07-21

Start date

2009-12-24

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Zoster MedDRA version: 12.0 Level: LLT Classification code 10019974 Term: Herpes zoster MedDRA version: 12.0 Level: LLT Classification code 10036897 Term: Prophylactic vaccination MedDRA version: 12.0 Level: LLT Classification code 10023438 Term: Kidney transplant

Interventions

Trade Name: Zostavax Product Name: Zostavax Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: shingles (herpes zoster) vaccine (live) CAS Number: 0 Other descript

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

Exclusion criteria

Exclusion criteria: - Use of immunosuppresion (inhalation corticosteroids are allowed) - Neomycine allergy - Fever - Immunodeficiency due to e.g. acute/chronic, lymphoma or HIV - Active tuberculosis

Design outcomes

Primary

Measure	Time frame
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). VZV-specific T-cell reactivity using flow cytometry specific from baseline to endpoint.	—

Measure

Time frame

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). VZV-specific T-cell reactivity using flow cytometry specific from baseline to endpoint.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026