Herpes Zoster Vaccine for Bone Marrow Transplant Donors

NCT ID: NCT01573182

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2018-05-03

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.

Detailed Description

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.

Conditions

Herpes Zoster

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Donor

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..

Group Type: EXPERIMENTAL

Zostavax

Intervention Type: 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.

Interventions

Zostavax

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sydney

OTHER

Sponsor Role: lead

Responsible Party

David Gottlieb

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Gottlieb

Role: PRINCIPAL_INVESTIGATOR

Westmead Hospital

Locations

Westmead Hospital

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

VADOVAR

Identifier Type: -

Identifier Source: org_study_id