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Completed

NCT Number: NCT03192319

Optimal Timing of Zoster Vaccine 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).

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zostavax

Biological

Zostavax will be administrated by subcutaneous injection

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2017
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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