Optimal Timing of Zoster Vaccine After Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Herpes Zoster

Intervention / Treatment
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* Biological: Zostavax


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody titer against varicella-zoster virus | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herpes zoster vaccine, Cell-mediated immunity, hematopoietic stem cell transplantation