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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01573182




Registration number
NCT01573182
Ethics application status
Date submitted
29/03/2012
Date registered
6/04/2012
Date last updated
11/05/2018

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] 0 0
VADOVAR
Universal Trial Number (UTN)
Trial acronym
VZV-Zostavax
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Herpes Zoster 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Zostavax

Experimental: 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..


Treatment: Other: 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 code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of transplant recipients with VZV specific T cell proliferation within the first 12 moths post-transplant.
Timepoint [1] 0 0
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 outcome [1] 0 0
Donor VZV positivity by PCR and genotype and donor VZV specific T cell response to vaccination
Timepoint [1] 0 0
4 to 6 weeks after vaccination

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/05/2018
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01573182
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Gottlieb
Address 0 0
Westmead Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01573182