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Optimal Timing of Zoster Vaccine After Hematopoietic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT03192319
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Wan Beom Park, Seoul National University Hospital

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).

Condition or disease Intervention/treatment Phase
Herpes Zoster Biological: Zostavax Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Change in Humoral and Cellular Immunity Induced by Zoster Vaccine According to the Timing of Vaccination After Hematopoietic Stem Cell Transplantation
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192319


Contacts
Contact: Park Wan Beom, MD, PhD 82-2-2072-3596 wbpark1@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Wan Beom Park, MD, PhD    82-10-9624-5580    wbpark1@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Park Wan Beom, MD, PhD Seoul National University Hospital

Publications:
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. Erratum in: Biol Blood Marrow Transplant. 2010 Feb;16(2):294. Boeckh, Michael A [corrected to Boeckh, Michael J].

Responsible Party: Wan Beom Park, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03192319     History of Changes
Other Study ID Numbers: H1705030852
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wan Beom Park, Seoul National University Hospital:
Herpes zoster vaccine
Cell-mediated immunity
hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs