Herpes Zoster Vaccine for Bone Marrow Transplant Donors

NCT01573182 | Completed Phase 2

• 1 other identifier: VADOVAR
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Herpes Zoster

Keywords

Zostavax; Herpes Zoster; VZV vaccination; Allogeneic haemopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

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

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

  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

Secondary Outcomes (1)

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

  4 to 6 weeks after vaccination

Study Arms (1)

Donor

EXPERIMENTAL

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

Biological: Zostavax

Interventions

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.

Donor

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sydney: lead

Study Sites (1)

Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• David Gottlieb

  Westmead Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 6, 2012
• Study Start: April 1, 2012
• Primary Completion: May 3, 2018
• Study Completion: May 3, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

AU (1)