Safety and Immunogenicity of Zostavax Vaccine in Patients Undergoing Living Donor Kidney Transplantation

University of Alberta

Status and phase: Completed; Phase 4

Conditions: Kidney Transplant

Treatments: Biological: Zostavax (Live attenuated herpes zoster vaccine); Biological: Placebo vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00940940

DKUA-001

Details and patient eligibility

About

Varicella zoster virus is part of the herpesvirus group and causes chickenpox in exposed individuals. The majority of the population is seropositive for this virus. Reactivation of varicella zoster virus occurs in up to 30% of the general population over 60 years old.

Solid organ transplant recipients receive lifelong immunosuppression drugs and are at great risk of reactivation of all herpesviruses including the varicella zoster virus regardless of age. The vaccine has been shown to be effective in preventing shingles in the general population. The investigators' purpose is to determine how well the vaccine works in patients on renal replacement therapy and post-transplant.

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-65 years
2. Listed or will likely be listed for live donor kidney transplant within one month

Exclusion criteria

1. Previous receipt of Zostavax

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

---

4 participants in 2 patient groups, including a placebo group

Live attenuated herpes zoster vaccine

Experimental group

Treatment:

Biological: Zostavax (Live attenuated herpes zoster vaccine)

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo vaccine