Safety and Immunogenicity of Zostavax Vaccine in Patients... | NCT00940940

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

NCT00940940

Sponsor

University of Alberta

Status

Completed

Last Update Posted

Jun 1, 2022Actual

Enrollment

4Actual

Phase

Phase 4

Conditions

Kidney Transplant

Interventions

Zostavax (Live attenuated herpes zoster vaccine)
Placebo vaccine

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Aug 26, 2013Actual

Completion Date

Sep 23, 2013Actual

First Submitted Date

Jul 15, 2009

First Submission Date that Met QC Criteria

Jul 16, 2009

First Posted Date

Jul 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2022

Last Update Posted Date

Jun 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Live attenuated herpes zoster vaccine	Experimental		Biological: Zostavax (Live attenuated herpes zoster vaccine)
Placebo	Placebo Comparator		Biological: Placebo vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zostavax (Live attenuated herpes zoster vaccine)	Biological	0.6 mL subcutaneous	Live attenuated herpes zoster vaccine

Measure	Description	Time Frame
Immunogenicity		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Previous receipt of Zostavax

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deepali Kumar, MD	University of Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta Hospital		Edmonton	Alberta		Canada

Intervention Browse Module

MeSH Terms

ID	Term
D053061	Herpes Zoster Vaccine

Ancestor Terms

ID	Term
D019433	Chickenpox Vaccine
D022283	Herpesvirus Vaccines
D014765	Viral Vaccines
D014612	Vaccines

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Browse Branches

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