VZV Vaccine for Hematopoietic Stem Cell Transplantation (VZIDST)
Efficacy and Safety of a Novel Intradermal Live-attenuated Varicella Zoster Vaccine in Hematopoietic Stem Cell Transplantation Donors: a Randomized Double Blind Placebo-controlled Trial
研究概览
详细说明
Hematopoietic stem cell transplantation (HSCT) is well-established therapy for patients with malignant hematological diseases. Varicella zoster virus (VZV) reactivation, clinically manifested as herpes zoster (HZ), is a major complication that affects up to 50% of patients. Most patients will require hospitalization. Despite treatment with high dose acyclovir, patients may develop severe complications including the disabling postherpetic neuralgia, corneal ulceration, viral dissemination and secondary bacterial infection. The median onset of infection is the fifth month following transplantation, with 91% of cases occurring within the first year. Direct vaccination of transplants recipients with subcutaneous live-attenuated VZVv before transplantation and up to one year after transplantation is contraindicated. A small prospective non-randomized study has demonstrated that subcutaneous vaccination for donors before HSCT may offer some protection against VZV reactivation in the recipients. Recently, dose-sparing influenza vaccine delivered via a novel intradermal microneedle has been shown to elicit a good immunogenic response in both healthy and elderly subjects. We sought to assess the efficacy and safety of the novel intradermal live-attenuated VZVv in sibling donors undergoing HSCT.
We plan to enroll 160 pairs of adult donors and patients who undergo allogeneic HLA matched sibling HSCT in this prospective randomized double-blind placebo-controlled trial over a period of 3 years. Enrolled donors and patients will be randomized into 4 groups: Group 1: intradermal full dose live-attenuated VZVv; Group 2: subcutaneous full dose live-attenuated VZVv; Group 3: intradermal 0.9% normal saline as control; Group 4: subcutaneous 0.9% normal saline as the second control
All vaccines will be given to the donors within 28 days before HSCT. All intradermal vaccines will be given via a microneedle syringe. Both the investigators and participants will be blinded to the randomization process. The primary end point is the occurrence of HZ in the patients within 12 months of transplantation. The secondary end points are the safety and immunological response in the patients and donors.
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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Hong Kong、香港
- Ivan Hung
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients undergoing allogeneic hemopoietic stem cell transplant
- HLA identical sibling donors
- participants willing to provide written informed consents
Exclusion Criteria:
- history of zoster in the 12 months prior to transplantation
- exposure to VZV within 4 weeks of transplantation
- neomycin sensitivity
- sensitivity to any components of the zoster vaccine
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:ID varicella zoster vaccine (VZVv) group
intradermal 0.65 mL Zostavax
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varicella zoster vaccine
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有源比较器:SC VZVv group
subcutaneous 0.65 mL Zostavax
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varicella zoster vaccine
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安慰剂比较:ID NS Group
intradermal 0.65 mL normal saline
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normal saline placebo vaccine
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安慰剂比较:SC NS Group
subcutaneous 0.65 mL normal saline
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normal saline placebo vaccine
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Herpes Zoster Reactivation
大体时间:12 months post transplantation
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Incidence of herpes zoster in stem-cell transplant recipients
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12 months post transplantation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Immunological response in recipients
大体时间:30, 90, 180 and 360 days post transplantation
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Geometric mean concentration of anti-VZV antibody (IU/mL)
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30, 90, 180 and 360 days post transplantation
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Immunological response in donors
大体时间:30, 90, 180 and 360 days post transplantation
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Geometric mean concentration of anti-VZV antibody (IU/mL)
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30, 90, 180 and 360 days post transplantation
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Adverse reaction
大体时间:21 days after vaccination
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Rate of adverse reaction in donors after vaccination
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21 days after vaccination
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合作者和调查者
出版物和有用的链接
一般刊物
- Hata A, Asanuma H, Rinki M, Sharp M, Wong RM, Blume K, Arvin AM. Use of an inactivated varicella vaccine in recipients of hematopoietic-cell transplants. N Engl J Med. 2002 Jul 4;347(1):26-34. doi: 10.1056/NEJMoa013441.
- Leung AY, Chow HC, Kwok JS, Lui CK, Cheng VC, Yuen KY, Lie AK, Liang R. Safety of vaccinating sibling donors with live-attenuated varicella zoster vaccine before hematopoietic stem cell transplantation. Bone Marrow Transplant. 2007 Jun;39(11):661-5. doi: 10.1038/sj.bmt.1705673. Epub 2007 Apr 9.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- HKU 11-174
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