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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

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 Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 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
Actual Study Start Date : December 2014
Actual Primary Completion Date : September 2019
Actual Study Completion Date : October 2019

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 0.65 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 0.65 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




Primary Outcome Measures :
  1. Herpes Zoster Reactivation [ Time Frame: 12 months post transplantation ]
    Incidence of herpes zoster in stem-cell transplant recipients


Secondary Outcome Measures :
  1. Immunological response in recipients [ Time Frame: 30, 90, 180 and 360 days post transplantation ]
    Geometric mean concentration of anti-VZV antibody (IU/mL)

  2. Immunological response in donors [ Time Frame: 30, 90, 180 and 360 days post transplantation ]
    Geometric mean concentration of anti-VZV antibody (IU/mL)

  3. Adverse reaction [ Time Frame: 21 days after vaccination ]
    Rate of 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


Locations
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Hong Kong
Ivan Hung
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Ivan FN Hung, MD FRCP The University of Hong Kong
Publications of Results:
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02329457    
Other Study ID Numbers: HKU 11-174
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Keywords provided by The University of Hong Kong:
double-blind, randomized, intradermal, VZVv, HSCT
Additional relevant MeSH terms:
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Herpes Zoster
Chickenpox
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases