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VZV Vaccine for Hematopoietic Stem Cell Transplantation (VZIDST)

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ClinicalTrials.gov Identifier: NCT02329457
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Varicella Zoster Infection Biological: Zostavax Biological: Normal Saline Not Applicable

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 reduced 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; Group 5: intradermal reduced dose live-attenuated VZVv with topical imiquimod pretreatment.

All vaccines will be given to the donors at 28 days. 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 points are the safety and immunological response in the donors. The secondary end point is the occurrence of HZ in the patients within 12 months of transplantation.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : December 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chickenpox Shingles

Arm Intervention/treatment
Experimental: ID varicella zoster vaccine (VZVv) group
intradermal 0.2 mL Zostavax
Biological: Zostavax
varicella zoster vaccine

Active Comparator: SC VZVv group
subcutaneous 0.65 mL Zostavax
Biological: Zostavax
varicella zoster vaccine

Placebo Comparator: ID NS Group
intradermal 0.2 mL normal saline
Biological: Normal Saline
normal saline placebo vaccine

Placebo Comparator: SC NS Group
subcutaneous 0.65 mL normal saline
Biological: Normal Saline
normal saline placebo vaccine

Active Comparator: ID VZVv with imiquimod group
intradermal 0.2mL Zostavax with imiquimod pretreatment
Biological: Zostavax
varicella zoster vaccine




Primary Outcome Measures :
  1. Immunological response in donors [ Time Frame: 30 days post transplantation ]
    Anti-VZV antibody


Secondary Outcome Measures :
  1. Immunological response in donors [ Time Frame: 90, 180 and 360 days post transplantation ]
    Anti-VZV antibody

  2. Immunological response in donors [ Time Frame: 30 and 180 days post transplantation ]
    Cellular immunity assay

  3. Herpes zoster reactivation [ Time Frame: 12 months post transplantation ]
    Herpes zoster reactivation in recipients

  4. Adverse reaction [ Time Frame: 21 days after vaccination ]
    Adverse reaction in donors after vaccination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329457


Contacts
Contact: Ivan FN Hung, MD FRCP 852-22554049 ivanfn@gmail.com

Locations
Hong Kong
Ivan Hung Recruiting
Hong Kong, Hong Kong
Contact: Ivan FN Hung, MD FRCP    852 22554049    ivanfn@gmail.com   
Sub-Investigator: Kelvin To, MD FRCPath         
Sub-Investigator: KY Yuen, MD FRCPath         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Ivan FN Hung, MD FRCP The University of Hong Kong

Publications of Results:
Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02329457     History of Changes
Other Study ID Numbers: HKU 11-174
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Keywords provided by The University of Hong Kong:
double-blind, randomized, intradermal, VZVv, HSCT

Additional relevant MeSH terms:
Herpes Zoster
Chickenpox
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs