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NCT Number: NCT01573182

Herpes Zoster Vaccine for Bone Marrow Transplant Donors

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.

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Westmead Hospital

Sydney, New South Wales, 2145, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Allogeneic HSCT Recipient-donor pair
  • Donor aged 50 years and over
  • Recipients and donors willing to be recruited as a pair to this study
  • Recipients undergoing myeloablative or non myeloablative non T cell depleted, allogeneic stem cell transplants from HLA identical or 1 HLA antigen mismatched siblings.

Exclusion criteria

  • Lack of informed consent
  • Inability to recruit donor and recipient as a pair
  • Autologous transplant
  • Contraindication to Zostavax in donor
  • Donor aged <50 years
  • Recipient VZV immunoglobulin G (IgG) negative pre-transplantation,
  • Donor VZV IgG negative
  • Pregnancy of donor at randomisation
  • Inability to follow study protocol (donor and recipient)
  • Malignancy or immunosuppression of HSC donor
  • Expected HSCT within 30 to 42 days

Treatment and study plan

Zostavax

Biological

VZV seropositive donors 50 years and over will receive vaccination with a live attenuated herpes zoster vaccine (Zostavax) by the IM route 4 to 6 weeks prior to stem cell harvesting.

Primary outcomes

  1. Percentage of transplant recipients with VZV specific T cell proliferation within the first 12 moths post-transplant.

    Time frame: incidence of VZV specific T cell proliferation in the first 12 months post allogeneic stem cell transplant in recipients receiving stem cells from Zostavax vaccinated donors

    VZV specific T cell proliferation will be assessed at 3, 6, 9 and 12 months post transplant in stem cell transplant recipients.

Secondary outcomes

  1. Donor VZV positivity by PCR and genotype and donor VZV specific T cell response to vaccination

    Time frame: 4 to 6 weeks after vaccination

    Donor VZV positivity by PCR and VZV specific T cell proliferation will be assessed 4 to 6 weeks after vaccination.

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Registry information

Official study 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

Acronym: VZV-Zostavax

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2012
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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