Herpes Zoster Clinical Trial
Official title:
A Phase II Clinical Trial of Vaccination of Stem Cell Donors With Zostavax to Reduce the Incidence of Herpes Zoster in Transplant Recipients - A Pilot Study
The purpose of this study is to determine whether vaccination of stem cell donors with
Zostavax can reduce the rate of Herpes Zoster reactivations in transplant recipients.
The clinical hypotheses is: 1) that Zostavax given to stem cell donors will induce protective
VZV specific T cell proliferation in allogeneic stem cell transplant recipients that can be
transferred to recipients; 2) and that donor vaccination with Zostavax is safe for transplant
recipients as measured by viral load measurement by polymerase chain reaction assay (PCR) at
the time of stem cell donation.
Infection is a major cause of morbidity and death among haemopoietic stem cell
transplantation patients (HSCTs). Beyond the initial post-transplant (BMT) phase of
neutropenia, the most common infections are cytomegalovirus (CMV) and fungal infections.
Another common infection for which BMT patients are at increased risk is varicella-zoster
virus (VZV) (both primary varicella and herpes zoster). VZV infection is controlled by
specific T cell responses that are impaired post stem cell transplant.
Heat inactivated VZV vaccine has been shown to more than halve the incidence of herpes zoster
in adult BMT patients undergoing autologous transplantation. Clinical protection was
correlated with in vitro CD4 T-cell proliferation in response to varicella-zoster virus.
Being a live vaccine, attenuated VZV and (herpes zoster (HZ) vaccines are contraindicated
within 24 months after allogeneic HSCT. However, priming of donor T-cells with herpes zoster
vaccine may be a feasible alternative. One possible complication is the transfer of live
virus from vaccinated donors to immunocompromised stem cell transplant recipients.
Normal donors donating for HLA matched siblings will be vaccinated with the Varivax vaccine
prior to donation. Stem cell products will be assessed at the time of donation for evidence
of VZV by PCR and for response to vaccination by T cell proliferation. Transfer of VZV
proliferative responses in transplant recipients will be assessed by VZV specific T cell
proliferation at 3, 6, 9 and 12 months post transplantation.
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