NCT02329457

Brief Summary

Hematopoietic stem cell transplantation (HSCT) is well-established therapy for patients with malignant hematological diseases. Varicella zoster virus (VZV) reactivation, clinically manifested as herpes zoster (HZ), is a major complication that affects up to 50% of patients. Most patients will require hospitalization. Despite treatment with high dose acyclovir, patients may develop severe complications including the disabling postherpetic neuralgia, corneal ulceration, viral dissemination and secondary bacterial infection. The median onset of infection is the fifth month following transplantation, with 91% of cases occurring within the first year. Direct vaccination of transplants recipients with subcutaneous live-attenuated VZVv before transplantation and up to one year after transplantation is contraindicated. A small prospective non-randomized study has demonstrated that subcutaneous vaccination for donors before HSCT may offer some protection against VZV reactivation in the recipients. Recently, dose-sparing influenza vaccine delivered via a novel intradermal microneedle has been shown to elicit a good immunogenic response in both healthy and elderly subjects. We sought to assess the efficacy and safety of the novel intradermal live-attenuated VZVv in sibling donors undergoing HSCT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2014

Longer than P75 for phase_2

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

Study Start

First participant enrolled

December 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

4.8 years

First QC Date

December 29, 2014

Last Update Submit

October 21, 2019

Conditions

Varicella Zoster Infection

Keywords

double-blind, randomized, intradermal, VZVv, HSCT

Outcome Measures

Primary Outcomes (1)

  • Herpes Zoster Reactivation

    Incidence of herpes zoster in stem-cell transplant recipients

    12 months post transplantation

Secondary Outcomes (3)

  • Immunological response in recipients

    30, 90, 180 and 360 days post transplantation

  • Immunological response in donors

    30, 90, 180 and 360 days post transplantation

  • Adverse reaction

    21 days after vaccination

Study Arms (4)

ID varicella zoster vaccine (VZVv) group

EXPERIMENTAL

intradermal 0.65 mL Zostavax

Biological: Zostavax

SC VZVv group

ACTIVE COMPARATOR

subcutaneous 0.65 mL Zostavax

Biological: Zostavax

ID NS Group

PLACEBO COMPARATOR

intradermal 0.65 mL normal saline

Biological: Normal Saline

SC NS Group

PLACEBO COMPARATOR

subcutaneous 0.65 mL normal saline

Biological: Normal Saline

Interventions

ZostavaxBIOLOGICAL

varicella zoster vaccine

ID varicella zoster vaccine (VZVv) groupSC VZVv group
Normal SalineBIOLOGICAL

normal saline placebo vaccine

ID NS GroupSC NS Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients undergoing allogeneic hemopoietic stem cell transplant
  • HLA identical sibling donors
  • participants willing to provide written informed consents

You may not qualify if:

  • history of zoster in the 12 months prior to transplantation
  • exposure to VZV within 4 weeks of transplantation
  • neomycin sensitivity
  • sensitivity to any components of the zoster vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivan Hung

Hong Kong, Hong Kong

Location

Related Publications (2)

  • Hata A, Asanuma H, Rinki M, Sharp M, Wong RM, Blume K, Arvin AM. Use of an inactivated varicella vaccine in recipients of hematopoietic-cell transplants. N Engl J Med. 2002 Jul 4;347(1):26-34. doi: 10.1056/NEJMoa013441.

    PMID: 12097537RESULT

  • Leung AY, Chow HC, Kwok JS, Lui CK, Cheng VC, Yuen KY, Lie AK, Liang R. Safety of vaccinating sibling donors with live-attenuated varicella zoster vaccine before hematopoietic stem cell transplantation. Bone Marrow Transplant. 2007 Jun;39(11):661-5. doi: 10.1038/sj.bmt.1705673. Epub 2007 Apr 9.

    PMID: 17417658RESULT

MeSH Terms

Conditions

Varicella Zoster Virus Infection

Interventions

Herpes Zoster VaccineSaline Solution

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Chickenpox VaccineHerpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex MixturesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ivan FN Hung, MD FRCP

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2014

First Posted

December 31, 2014

Study Start

December 1, 2014

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

October 24, 2019

Record last verified: 2019-10

Locations

HK(1)