Comparison of Change in Humoral and Cellular Immunity Induced by Zoster Vaccine According to the Timing of Vaccination After Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Varicella-zoster virus-specific interferon-gamma ELISPOT response
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
5years to 10years after HCT
Patients will be vaccinated with Zostavax from 5years to 10years after hematopoietic stem cell transplantation
干预措施: Zostavax (Biological)
6 month after chemotherapy for leukemia
Patients will be vaccinated with Zostavax 6 months after the leukemia is cured with chemotherapy
干预措施: Zostavax (Biological)
healthy people
Healthy adults over 50 years old will be vaccinated with Zostavax
干预措施: Zostavax (Biological)
2years to 5years after HCT
Patients will be vaccinated with Zostavax from 2years to 5years after hematopoietic stem cell transplantation
干预措施: Zostavax (Biological)
结局指标
主要结局
Varicella-zoster virus-specific interferon-gamma ELISPOT response
时间窗: 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.
次要结局
- Antibody titer against varicella-zoster virus(before Zostavax vaccination and at week 6 after vaccination)
研究者
Wan Beom Park
Associate Professor
Seoul National University Hospital