A Phase 2 Clinical Trial to Evaluate the Safety, Immunogenicity, and Clinical Benefit of a CMV Immunotherapeutic Vaccine in Donors and CMV-Seropositive Recipients Undergoing Allogeneic, Matched Hematopoietic Cell Transplant (HCT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 22
- 主要终点
- Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT
研究概览
简要总结
The purpose of this trial is to evaluate a CMV vaccine given to related donor/recipient pairs (donors prior to peripheral blood stem cell donation and CMV-seropositive recipients just before and after transplantation) and CMV-seropositive recipient-only subjects (related or unrelated) to determine incidence rates of CMV infection, disease, and other complications from immunosuppression and/or transplantation. The outcomes for the groups receiving CMV vaccine will be compared to the outcomes for the group that received the placebo vaccine to see if there is a clinical benefit. For this trial, donors and recipients must have matched HLA genotype (matched at 5/6 or 6/6 HLA loci).
详细描述
This study was run by Vical and the record was transferred to Astellas on 1/8/2013.
Trial will enroll up to 240 subjects (160 recipients and 80 donors). Qualified donors and/or CMV-seropositive recipients (donor/recipient pairs or recipient-only subjects) will be assigned randomly to receive either a CMV vaccine or a placebo vaccine. Donors will receive 3 vaccines prior to donation and recipients will receive 1 vaccine pretransplant and up to three vaccines posttransplant. Recipients will be followed for up to 1 year after transplant to evaluate the safety of the vaccine and to see if there is a clinical benefit in the group that received the CMV vaccine. The incidence rates of CMV infection, disease, and other complications from immunosuppression and/or transplantation will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females age 18-65
- •5/6 or 6/6 classic HLA allele-matched donor
- •planned GCSF-mobilized peripheral blood stem cell transplant
- •CMV-seropositive recipient
- •planned transplant with minimal or no T-cell depletion
- •Acute Lymphoblastic Leukemia (ALL) in first or second remission; Acute Myeloid Leukemia (AML) in first or second remission; Chronic Myelogenous Leukemia (CML) in first chronic or accelerated phase, or in second chronic phase; Hodgkin's and non-Hodgkin's lymphoma; myelodysplastic syndrome
排除标准
- •planned prophylactic cytomegalovirus antiviral therapy
- •planned immunosuppression with alemtuzumab (CAMPATH-IH)
- •planned prophylactic therapy with CMV immunoglobulin
- •autoimmune disease
研究组 & 干预措施
Placebo
PBS
干预措施: Phosphate-buffered Saline (PBS) (Other)
VCL-CB01
干预措施: VCL-CB01 (Biological)
结局指标
主要结局
Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT
时间窗: 1 year
occurrence rate of clinically significant CMV viremia in recipients receiving CMV immunotherapeutic vaccine.
时间窗: 1 year
次要结局
未报告次要终点