NCT03192319

Brief Summary

The purpose of this study is to determine the optimal timing of zoster vaccination to induce both higher cell-mediated immunity and humoral immunity in adult patient aged over 50 with history of hematopoietic stem cell transplantation(HSCT).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2018

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

June 16, 2017

Last Update Submit

April 2, 2019

Conditions

Herpes Zoster

Keywords

Herpes zoster vaccineCell-mediated immunityhematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Varicella-zoster virus-specific interferon-gamma ELISPOT response

    Investigators measure the number of SFC(spot forming cells) using interferon-gamma ELISPOT(enzyme-linked immunospot) assay at both right before vaccination and week 6 after vaccination and see the change between two values.

    before Zostavax vaccination and at week 6 after vaccination

Secondary Outcomes (1)

  • Antibody titer against varicella-zoster virus

    before Zostavax vaccination and at week 6 after vaccination

Study Arms (4)

2years to 5years after HCT

EXPERIMENTAL

Patients will be vaccinated with Zostavax from 2years to 5years after hematopoietic stem cell transplantation

Biological: Zostavax

5years to 10years after HCT

ACTIVE COMPARATOR

Patients will be vaccinated with Zostavax from 5years to 10years after hematopoietic stem cell transplantation

Biological: Zostavax

6 month after chemotherapy for leukemia

ACTIVE COMPARATOR

Patients will be vaccinated with Zostavax 6 months after the leukemia is cured with chemotherapy

Biological: Zostavax

healthy people

ACTIVE COMPARATOR

Healthy adults over 50 years old will be vaccinated with Zostavax

Biological: Zostavax

Interventions

ZostavaxBIOLOGICAL

Zostavax will be administrated by subcutaneous injection

2years to 5years after HCT5years to 10years after HCT6 month after chemotherapy for leukemiahealthy people

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 50 years or older who is at least 2 years after hematopoietic stem cell transplantation (Experimental group)
  • Adults aged 50 years or older who is at least 6 months after being cured by chemotherapy for leukemia (Control group)

You may not qualify if:

  • Adults who can understand and agreed with the informed consents
  • Adults who have conditions which is contraindication for zoster vaccine
  • Adults who take immunosuppressant
  • Adults with graft versus host disease(GVHD)
  • Adults who take antivirals agent
  • Adults who experienced VZV infection after hematopoietic stem cell transplantation
  • Adults who received VZV vaccination already after hematopoietic stem cell transplantation
  • Adults who are not eligible for zoster vaccination by investigator's assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (5)

  • Tomblyn M, Chiller T, Einsele H, Gress R, Sepkowitz K, Storek J, Wingard JR, Young JA, Boeckh MJ; Center for International Blood and Marrow Research; National Marrow Donor program; European Blood and MarrowTransplant Group; American Society of Blood and Marrow Transplantation; Canadian Blood and Marrow Transplant Group; Infectious Diseases Society of America; Society for Healthcare Epidemiology of America; Association of Medical Microbiology and Infectious Disease Canada; Centers for Disease Control and Prevention. Guidelines for preventing infectious complications among hematopoietic cell transplantation recipients: a global perspective. Biol Blood Marrow Transplant. 2009 Oct;15(10):1143-238. doi: 10.1016/j.bbmt.2009.06.019. No abstract available.

    PMID: 19747629BACKGROUND

  • Issa NC, Marty FM, Leblebjian H, Galar A, Shea MM, Antin JH, Soiffer RJ, Baden LR. Live attenuated varicella-zoster vaccine in hematopoietic stem cell transplantation recipients. Biol Blood Marrow Transplant. 2014 Feb;20(2):285-7. doi: 10.1016/j.bbmt.2013.11.013. Epub 2013 Nov 22.

    PMID: 24269706BACKGROUND

  • Gilbert PB, Gabriel EE, Miao X, Li X, Su SC, Parrino J, Chan IS. Fold rise in antibody titers by measured by glycoprotein-based enzyme-linked immunosorbent assay is an excellent correlate of protection for a herpes zoster vaccine, demonstrated via the vaccine efficacy curve. J Infect Dis. 2014 Nov 15;210(10):1573-81. doi: 10.1093/infdis/jiu279. Epub 2014 May 13.

    PMID: 24823623BACKGROUND

  • Kim JW, Min CK, Mun YC, Park Y, Kim BS, Nam SH, Koh Y, Kwon JH, Choe PG, Park WB, Kim I. Varicella-zoster virus-specific cell-mediated immunity and herpes zoster development in multiple myeloma patients receiving bortezomib- or thalidomide-based chemotherapy. J Clin Virol. 2015 Dec;73:64-69. doi: 10.1016/j.jcv.2015.10.018. Epub 2015 Oct 24.

    PMID: 26546878BACKGROUND

  • Levin MJ, Oxman MN, Zhang JH, Johnson GR, Stanley H, Hayward AR, Caulfield MJ, Irwin MR, Smith JG, Clair J, Chan IS, Williams H, Harbecke R, Marchese R, Straus SE, Gershon A, Weinberg A; Veterans Affairs Cooperative Studies Program Shingles Prevention Study Investigators. Varicella-zoster virus-specific immune responses in elderly recipients of a herpes zoster vaccine. J Infect Dis. 2008 Mar 15;197(6):825-35. doi: 10.1086/528696.

    PMID: 18419349BACKGROUND

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Chickenpox VaccineHerpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Park Wan Beom, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 20, 2017

Study Start

July 1, 2017

Primary Completion

August 23, 2018

Study Completion

August 23, 2018

Last Updated

April 4, 2019

Record last verified: 2019-04

Locations

KR(1)