Sponsor study identifier
interventional
100
1 country
1
Study Start
December 2014
Actual (reported)Primary Completion
September 2019
Actual (reported)Study Completion
October 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2014
Actual (reported)December 29, 2014
Actual (reported)December 31, 2014
Actual (reported)September 2019
Actual (reported)October 2019
Actual (reported)Herpes Zoster Reactivation
Incidence of herpes zoster in stem-cell transplant recipients
12 months post transplantation
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
intradermal 0.65 mL Zostavax
subcutaneous 0.65 mL Zostavax
intradermal 0.65 mL normal saline
varicella zoster vaccine
normal saline placebo vaccine
Ivan Hung
Hong Kong, Hong Kong
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.
Ivan FN Hung, MD FRCP
The University of Hong Kong
100 participants (actual enrollment reported by the registry).
First Submitted
December 29, 2014
First Posted
December 31, 2014
Study Start
December 2014
Actual (reported)Naloxone for Optimizing Hypoxemia Of Lung Donors
subcutaneous 0.65 mL normal saline
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Primary Completion
September 2019
Actual (reported)Study Completion
October 2019
Actual (reported)Last Updated
October 24, 2019
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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