drugset / Trial / NCT02329457

VZV Vaccine for Hematopoietic Stem Cell Transplantation

NCT02329457

Phase 2/3 Completed 100 enrolled The University of Hong Kong
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2014-12
Primary completion
2019-09
Completion
2019-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Varivax Vaccine 0.65 ml Intrathecal