Optimal Timing of Zoster Vaccine After Hematopoietic Stem Cell Transplantation

April 2, 2019 updated by: Wan Beom Park, Seoul National University Hospital

Comparison of Change in Humoral and Cellular Immunity Induced by Zoster Vaccine According to the Timing of Vaccination After Hematopoietic Stem Cell Transplantation

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Due to lack of data on safety of live vaccine in the recipient of hematopoietic stem cell transplantation, CIBMTR(Center for International Blood and Marrow Transplant Research) guidelines recommend varicella vaccination only in patients who is at least two years after transplantation and without graft versus host disease and no immunosuppressive drug.

However, recent studies have demonstrated the safety and efficacy of shingles vaccination in patients receiving hematopoietic stem cell transplantation.

But, there is no basis for timing of live vaccine administration after HSCT.

The investigators plan to make scientific recommendation for optimal timing of zoster vaccine after HSCT by comparing immune response between two groups(vaccination at 2 to 5years after HSCT vs. 5 to 10years after HSCT). Primary outcome is interferon gamma releasing ELISPOT response at week 6 after vaccination. Secondary outcome is ELISA titer for zoster-specific IgG at week 6 after vaccination.

All the patients will be asked if they have any contraindication for zoster vaccine by a physician before vaccination. And they will be monitored for any adverse reaction of the vaccination after 6 weeks(visiting the hospital).

In order to confirm the efficacy of the experiment, 30 healthy controls and 30 patients who were treated with chemotherapy alone for leukemia were selected. The control group will also apply the same protocol as above.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)
  • Healthy Adults aged 50 years or older who do not meet exclusion criteria (Control group)
  • Adults who can understand and agreed with the informed consents

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2years to 5years after HCT
Patients will be vaccinated with Zostavax from 2years to 5years after hematopoietic stem cell transplantation
Biological: Zostavax
Zostavax will be administrated by subcutaneous injection
Active Comparator: 5years to 10years after HCT
Patients will be vaccinated with Zostavax from 5years to 10years after hematopoietic stem cell transplantation
Biological: Zostavax
Zostavax will be administrated by subcutaneous injection
Active Comparator: 6 month after chemotherapy for leukemia
Patients will be vaccinated with Zostavax 6 months after the leukemia is cured with chemotherapy
Biological: Zostavax
Zostavax will be administrated by subcutaneous injection
Active Comparator: healthy people
Healthy adults over 50 years old will be vaccinated with Zostavax
Biological: Zostavax
Zostavax will be administrated by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Varicella-zoster virus-specific interferon-gamma ELISPOT response
Time Frame: before Zostavax vaccination and at week 6 after vaccination
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody titer against varicella-zoster virus
Time Frame: before Zostavax vaccination and at week 6 after vaccination
Investigators measure the titer of Varicella zoster virus (VZV)-specific Ab by enzyme-linked immunosorbent assay at both right before vaccination and week 6 after vaccination and see the fold change between two values
before Zostavax vaccination and at week 6 after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Park Wan Beom, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

August 23, 2018

Study Completion (Actual)

August 23, 2018

Study Registration Dates

First Submitted

June 16, 2017

First Submitted That Met QC Criteria

June 16, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1705030852

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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