Optimal Timing of Zoster Vaccine After Hematopoietic Stem Cell Transplantation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03192319

Enrollment

Registered

2017-06-20

Start date

2017-07-01

Completion date

2018-08-23

Last updated

2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Zoster

Keywords

Herpes zoster vaccine, Cell-mediated immunity, hematopoietic stem cell transplantation

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).

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.

Interventions

BIOLOGICALZostavax

Zostavax will be administrated by subcutaneous injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Varicella-zoster virus-specific interferon-gamma ELISPOT response	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

Measure	Time frame	Description
Antibody titer against varicella-zoster virus	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026