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Trial record 1 of 1 for:    02329457
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VZV Vaccine for Hematopoietic Stem Cell Transplantation (VZIDST)

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ClinicalTrials.gov Identifier: NCT02329457
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE December 29, 2014
First Posted Date  ICMJE December 31, 2014
Last Update Posted Date October 24, 2019
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
Herpes Zoster Reactivation [ Time Frame: 12 months post transplantation ]
Incidence of herpes zoster in stem-cell transplant recipients
Original Primary Outcome Measures  ICMJE
 (submitted: December 29, 2014)
Immunological response in donors [ Time Frame: 30 days post transplantation ]
Anti-VZV antibody
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
  • Immunological response in recipients [ Time Frame: 30, 90, 180 and 360 days post transplantation ]
    Geometric mean concentration of anti-VZV antibody (IU/mL)
  • Immunological response in donors [ Time Frame: 30, 90, 180 and 360 days post transplantation ]
    Geometric mean concentration of anti-VZV antibody (IU/mL)
  • Adverse reaction [ Time Frame: 21 days after vaccination ]
    Rate of adverse reaction in donors after vaccination
Original Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2014)
  • Immunological response in donors [ Time Frame: 90, 180 and 360 days post transplantation ]
    Anti-VZV antibody
  • Immunological response in donors [ Time Frame: 30 and 180 days post transplantation ]
    Cellular immunity assay
  • Herpes zoster reactivation [ Time Frame: 12 months post transplantation ]
    Herpes zoster reactivation in recipients
  • Adverse reaction [ Time Frame: 21 days after vaccination ]
    Adverse reaction in donors after vaccination
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VZV Vaccine for Hematopoietic Stem Cell Transplantation
Official Title  ICMJE Efficacy and Safety of a Novel Intradermal Live-attenuated Varicella Zoster Vaccine in Hematopoietic Stem Cell Transplantation Donors: a Randomized Double Blind Placebo-controlled Trial
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.
Detailed Description

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.

We plan to enroll 160 pairs of adult donors and patients who undergo allogeneic HLA matched sibling HSCT in this prospective randomized double-blind placebo-controlled trial over a period of 3 years. Enrolled donors and patients will be randomized into 4 groups: Group 1: intradermal full dose live-attenuated VZVv; Group 2: subcutaneous full dose live-attenuated VZVv; Group 3: intradermal 0.9% normal saline as control; Group 4: subcutaneous 0.9% normal saline as the second control

All vaccines will be given to the donors within 28 days before HSCT. All intradermal vaccines will be given via a microneedle syringe. Both the investigators and participants will be blinded to the randomization process. The primary end point is the occurrence of HZ in the patients within 12 months of transplantation. The secondary end points are the safety and immunological response in the patients and donors.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Varicella Zoster Infection
Intervention  ICMJE
  • Biological: Zostavax
    varicella zoster vaccine
  • Biological: Normal Saline
    normal saline placebo vaccine
Study Arms  ICMJE
  • Experimental: ID varicella zoster vaccine (VZVv) group
    intradermal 0.65 mL Zostavax
    Intervention: Biological: Zostavax
  • Active Comparator: SC VZVv group
    subcutaneous 0.65 mL Zostavax
    Intervention: Biological: Zostavax
  • Placebo Comparator: ID NS Group
    intradermal 0.65 mL normal saline
    Intervention: Biological: Normal Saline
  • Placebo Comparator: SC NS Group
    subcutaneous 0.65 mL normal saline
    Intervention: Biological: Normal Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2019)
100
Original Estimated Enrollment  ICMJE
 (submitted: December 29, 2014)
120
Actual Study Completion Date  ICMJE October 2019
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02329457
Other Study ID Numbers  ICMJE HKU 11-174
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ivan FN Hung, MD FRCP The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP