Phase II, Non-randomized, Open-label Study to Assess the Immunogenicity and Clinical Efficacy of the Recombinant Zoster Vaccine for Recipients of an Allogeneic Hematopoietic Stem Cell Transplant
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cell mediated and humoral immune response
研究概览
简要总结
This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.
详细描述
Cell mediated immunity is severely compromised after an allogeneic stem cell transplantation. This results in an increased risk of zoster with its associated morbidity and mortality. Patients typically receive prophylactic antivirals for 1 year after AlloSCT which reduces the incidence of zoster during this period. Unfortunately, after completing prophylaxis, patients continue to be at a significantly increased risk of zoster with an incidence rate of up to 29% at 3-years post transplant. The recombinant zoster vaccine provides immunogenicity and has shown clinical efficacy in preventing zoster in patients who have received an autologous transplant.
Furthermore, it has been shown to be safe in patients who had received an allogeneic transplant in a retrospective study although immunogenicity seemed to be decreased in this cohort. Due to the paucity of data in allogeneic recipients, we propose a prospective, non-randomized study to evaluate the immunogenicity and clinical efficacy of the recombinant zoster vaccine in recipients of allogeneic stem cell transplantation. As a secondary endpoint, we will compare our results to historical data of immunogenicity and clinical effectiveness of the vaccine in autologous transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •≥ 12 months and ≤ 36 months post-AlloSCT
- •Donor sources: matched related, matched unrelated, cord blood
- •Any malignant hematological disease including acute leukemia, myelodysplastic syndrome, non-Hodgkin's lymphoma, Hodgkin's lymphoma, chronic lymphocytic leukemia, chronic myeloid leukemia, multiple myeloma, and myeloproliferative disorders.
- •Any conditioning regimen
- •Any planned immunosuppressive prophylactic regimen
- •Patients with chronic graft-versus-host disease on stable immunosuppression
- •Ability to understand and the willingness to sign a written informed consent.
- •Negative pregnancy test in female patients of childbearing potential
排除标准
- •Patients who had zoster after an allogeneic transplant and prior to enrollment
- •Patients who are currently pregnant
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to the recombinant zoster vaccine, Shingrix, or other agents used in study.
- •Patients who have had a relapse of their primary hematological disease
- •Previous allogeneic stem cell transplantation
- •Acute disease at the time of vaccination
- •Thrombocytopenia that in the judgment of the investigator would make intramuscular injection unsafe.
研究组 & 干预措施
Shingrix
Patients 1-3 years post transplant will receive the Shingrix vaccine in standard dosing and schedule.
干预措施: Shingrix (Drug)
结局指标
主要结局
Cell mediated and humoral immune response
时间窗: Measured one month following eh last dose of vaccine received
次要结局
未报告次要终点
研究者
Hagen, Patrick A
Associate Professor
Loyola University