Herpes Zoster Vaccine for Bone Marrow Transplant donors

Phase 1

• Conditions: Varicella zoster in immunsuppressed stem cell transplant recipients; Infection - Other infectious diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12611000640909
• Lead Sponsor: MERCK SHARP & DOHME

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>Stem cell recipients will be assessed for any clinical symptoms.[3 months post allogeneic stem cell transplant in the recipient following donor vaccination with Zostavax.];Reduced incidence of suspected and proven Herpes Zoster infection in recipients. Clinical assessment.[first 12 months post-transplant]

Secondary Outcome Measures

Name	Time	Method
Donor VZV positivity by PCR (and genotype), donor VZV specific T cell proliferation will assessed by blood test.[At stem cell donation]