NCT00940940

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2013

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2015

Enrollment Period

3.9 years

First QC Date

July 15, 2009

Last Update Submit

May 26, 2022

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

  • Immunogenicity

    6 months

Study Arms (2)

Live attenuated herpes zoster vaccine

EXPERIMENTAL
Biological: Zostavax (Live attenuated herpes zoster vaccine)

Placebo

PLACEBO COMPARATOR
Biological: Placebo vaccine

Interventions

Zostavax (Live attenuated herpes zoster vaccine)BIOLOGICAL

0.6 mL subcutaneous

Also known as: Zostavax
Live attenuated herpes zoster vaccine
Placebo vaccineBIOLOGICAL

0.65 mL subcutaneous

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. Previous receipt of Zostavax

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

MeSH Terms

Interventions

Herpes Zoster Vaccine

Intervention Hierarchy (Ancestors)

Chickenpox VaccineHerpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Deepali Kumar, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2009

First Posted

July 17, 2009

Study Start

October 1, 2009

Primary Completion

August 26, 2013

Study Completion

September 23, 2013

Last Updated

June 1, 2022

Record last verified: 2015-05

Locations

CA(1)