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Trial registered on ANZCTR


Registration number
ACTRN12611000640909
Ethics application status
Approved
Date submitted
3/05/2011
Date registered
23/06/2011
Date last updated
23/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Herpes Zoster Vaccine for Bone Marrow Transplant donors
Scientific 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.
Secondary ID [1] 260006 0
None
Universal Trial Number (UTN)
Trial acronym
VAZDOVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Varicella zoster in immunsuppressed stem cell transplant recipients 265663 0
Condition category
Condition code
Infection 265808 265808 0 0
Other infectious diseases
Inflammatory and Immune System 265927 265927 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 264422 0
Prevention
Intervention code [2] 264514 0
Treatment: Drugs
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266548 0
To determine the VZV specific T cell proliferation induced by Zostavax given to allogeneic stem cell donors in the donors and in allogeneic stem cell transplant recipients aged 50 years.
3 months post allogeneic stem cell transplant in the recipient following donor vaccination with Zostavax. Blood test will be performed(Donor VZV positivity by PCR (and genotype) and donor VZV specific T cell proliferation will be assessed.
Stem cell recipients will be assessed for any clinical symptoms.
Timepoint [1] 266548 0
3 months post allogeneic stem cell transplant in the recipient following donor vaccination with Zostavax.
Primary outcome [2] 266549 0
Reduced incidence of suspected and proven Herpes Zoster infection in recipients. Clinical assessment.
Timepoint [2] 266549 0
first 12 months post-transplant
Secondary outcome [1] 276017 0
Donor VZV positivity by PCR (and genotype), donor VZV specific T cell proliferation will assessed by blood test.
Timepoint [1] 276017 0
At stem cell donation

Eligibility
Key inclusion criteria
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.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
20 allogeneic HSCT donor-recipient pairs will be approached to take part in this study if they meet the inclusion/exclusion criteria.
In this study, normal donors over the age of 50 years will be eligible to receive the vaccine.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There is no randomizaton
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Donor will receive a live Varicella Zoster vaccine by the subcutaneous route 4 to 6 weeks prior to stem cell collection. The vaccine contains live virus that has been treated to reduce its ability to cause infection. 10 mls of blood will be collected before the vaccination and at the time of stem cell collection. This study only requires up to 2 blood samples from donors. In the great majority of cases, this does not involve any additional blood sampling since blood samples are taken at the same time as tests are done for normal clinical care for the stem cell transplant. Recipient's blood will be sampled at 3, 6, 9 and 12 months for VZV induced proliferation.
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 264892 0
University
Name [1] 264892 0
Investigator Driven Study- University of Sydney
Country [1] 264892 0
Australia
Funding source category [2] 265002 0
Commercial sector/Industry
Name [2] 265002 0
MERCK SHARP & DOHME
Country [2] 265002 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
MERCK SHARP & DOHME
Address
54-68 Femdell St
South Granville, NSW 2142
Country
Australia
Secondary sponsor category [1] 263992 0
Hospital
Name [1] 263992 0
Westmead Hospital
Address [1] 263992 0
Cnr of Darcy and Hawkesbury Rd,
Westmead, NSW 2145
Country [1] 263992 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266860 0
Western Sydney, Local Health Network- Human Ethics and Research Committee (Westmead Campus)
Ethics committee address [1] 266860 0
Hawkesbury Rd
Westmead, NSW 2145
Ethics committee country [1] 266860 0
Australia
Date submitted for ethics approval [1] 266860 0
Approval date [1] 266860 0
10/02/2011
Ethics approval number [1] 266860 0
HREC2010/11/4.11(3186) AU RED HREC/10/WMEAD/158

Summary
Brief 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.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32493 0
Address 32493 0
Country 32493 0
Phone 32493 0
Fax 32493 0
Email 32493 0
Contact person for public queries
Name 15740 0
Prof Raina MacIntyre
Address 15740 0
Head of School and Professor of Infectious Diseases Epidemiology School of Public Health and Community Medicine | Faculty of Medicine | The University of New South Wales | Sydney, NSW, 2052
Country 15740 0
Australia
Phone 15740 0
61 2 9385 3811
Fax 15740 0
61 2 9313 6185
Email 15740 0
[email protected]
Contact person for scientific queries
Name 6668 0
Prof David Gottlieb
Address 6668 0
University of Sydney
Department of Medicine
Cnr of Darcy and Hawkesbury Rd
Westmead Hospital
Westmead, NSW 2145
Country 6668 0
Australia
Phone 6668 0
61 2 9845 6033
Fax 6668 0
61 2 9687 2331
Email 6668 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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