Not Yet RecruitingPhase 2ACTRN12611000640909

Herpes Zoster Vaccine for Bone Marrow Transplant donors

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.


Sponsor

MERCK SHARP & DOHME

Enrollment

20 participants

Start Date

Jul 1, 2011

Study Type

Interventional

Conditions

Summary

This investigator driven pilot study aims to determine whether vaccination of stem cell donors with Zostavax can reduce the rate of Herpes Zoster reactivations in transplant recipients. As we know, infection is a leading cause of morbidity among allogenic transplant patients. Varicella zoster virus reactivation is one of the commonest infections occurring following allogeneic transplant. Primary varicella infection in transplant recipients can cause serious widespread and sometimes fatal viral infection. Reactivation of Varicella known as herpes zoster or shingles can cause rash and severe prolonged pain known as neuralgia. Shingles typically presents as a localised skin rash. The most common complication of shingles is postherpetic neuralgia (PHN). Individuals who suffer from PHN report constant burning, throbbing, and intermittent sharp or electric shock-like pain. In a patient already recovering after chemoradiotherapy, primary varicella infection, shingles and PHN can markedly impair quality of life. ZOSTAVAX vaccine has been approved in Australia for the prevention of shingles and its complications in people 50 years of age and older. The purpose of the study is to find out whether vaccination of stem cell donors with Zostavax can reduce the infection rate of shingles in transplant recipients. We hypothesise that boosted immunity in these donors may transfer to recipients at the time of stem cell infusion and reduce the rate of shingles after transplant. Normal donors (Stem Cell Donors) over the age of 50 years will be eligible to receive the vaccine. Donors will receive vaccination once only by the subcutaneous route and be followed up for 1 week for any adverse reaction. We would report any adverse event among the stem cell donor related to vaccine to the Therapeutic Goods Administration via the "Blue Card" . Stem Cell recipients will be followed up for 12 months after their transplant.


Eligibility

Sex: Both males and femalesMin Age: 50 YearssMax Age: 80 Yearss

Inclusion Criteria4

  • Allogeneic HSCT Recipient-donor pair
  • Donor aged 50 years and over
  • Signed informed consent by donor and recipient
  • Recipients undergoing myeloablative or non myeloablative non T cell depleted allogeneic stem cell transplants from HLA identical or 1 HLA antigen mismatched siblings.

Exclusion Criteria11

  • 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 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

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Interventions

ZOSTAVAX vaccine has been approved in Australia for the prevention of shingles and its complications in people 50 years of age and older. The purpose of the study is to find out whether vaccination of

ZOSTAVAX vaccine has been approved in Australia for the prevention of shingles and its complications in people 50 years of age and older. The purpose of the study is to find out whether vaccination of stem cell donors with Zostavax can reduce the infection rate of shingles in transplant recipients. In this study, stem cell donors over the age of 50 years will be eligible to receive the vaccine. Donor will receive vaccination once only by the subcutaneous route (0.65mL shot). Stem Cell Donor will be followed up for 1 week after the vaccination for any adverse reaction. This is approved vaccine for normal healthy population who could also be stem cell donor. Stem Cell recipients will be followed up for 12 months after the transplant.


Locations(1)

NSW, Australia

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ACTRN12611000640909