- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02329457
VZV Vaccine for Hematopoietic Stem Cell Transplantation (VZIDST)
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Ivan Hung
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ID varicella zoster vaccine (VZVv) group
intradermal 0.65 mL Zostavax
|
varicella zoster vaccine
|
Active Comparator: SC VZVv group
subcutaneous 0.65 mL Zostavax
|
varicella zoster vaccine
|
Placebo Comparator: ID NS Group
intradermal 0.65 mL normal saline
|
normal saline placebo vaccine
|
Placebo Comparator: SC NS Group
subcutaneous 0.65 mL normal saline
|
normal saline placebo vaccine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Herpes Zoster Reactivation
Time Frame: 12 months post transplantation
|
Incidence of herpes zoster in stem-cell transplant recipients
|
12 months post transplantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunological response in recipients
Time Frame: 30, 90, 180 and 360 days post transplantation
|
Geometric mean concentration of anti-VZV antibody (IU/mL)
|
30, 90, 180 and 360 days post transplantation
|
Immunological response in donors
Time Frame: 30, 90, 180 and 360 days post transplantation
|
Geometric mean concentration of anti-VZV antibody (IU/mL)
|
30, 90, 180 and 360 days post transplantation
|
Adverse reaction
Time Frame: 21 days after vaccination
|
Rate of adverse reaction in donors after vaccination
|
21 days after vaccination
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HKU 11-174
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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