A Phase I Dose Escalation Study of Peptide Vaccines With Activity Against Human Cytomegalovirus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of each vaccine with or without adjuvant CpG 7909
研究概览
简要总结
RATIONALE: Vaccines made from peptides may help the body build an immune response to kill cytomegalovirus.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in preventing cytomegalovirus in healthy participants.
详细描述
OBJECTIVES:
Primary
- To establish whether 3 vaccine dose levels of PADRE-CMV and tetanus-CMV fusion peptide vaccines are safe and well tolerated in healthy cytomegalovirus (CMV)-seropositive or -seronegative participants.
- To establish safe dose levels for the PADRE-CMV and tetanus-CMV fusion peptide vaccines in combination with PF 03512676 DNA in these participants.
Secondary
- To provide preliminary evidence of enhanced cellular immunity to CMV at levels of T cells that would support potential feasibility if such cells were to be transferred from the donor to recipients of hematopoietic stem cell transplantation (HSCT) in amounts consistent with protection against disease.
- To determine whether a reduced dose of peptide vaccine can be immunogenic in combination with PF 03512676 DNA.
- To confer CMV-specific cytotoxic T-lymphocyte (CTL) function to CMV-negative participants.
- To determine the duration of immune enhancement of CMV-specific CTL function up to 12 months following immunization of healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A
Participants receive either PADRE-CMV fusion peptide vaccine or tetanus-CMV fusion peptide vaccine subcutaneously (SC) on days 1, 21, 42, and 63 in the absence of unacceptable toxicity.
干预措施: PADRE-CMV fusion peptide vaccine (Biological)
Group A
Participants receive either PADRE-CMV fusion peptide vaccine or tetanus-CMV fusion peptide vaccine subcutaneously (SC) on days 1, 21, 42, and 63 in the absence of unacceptable toxicity.
干预措施: tetanus-CMV fusion peptide vaccine (Biological)
Group B
Participants receive either PADRE-CMV fusion peptide vaccine in CpG 7909 adjuvant SC or tetanus-CMV fusion peptide vaccine in CpG 7909 adjuvant SC on days 1, 21, 42, and 63 in the absence of unacceptable toxicity.
干预措施: PADRE-CMV fusion peptide vaccine (Biological)
Group B
Participants receive either PADRE-CMV fusion peptide vaccine in CpG 7909 adjuvant SC or tetanus-CMV fusion peptide vaccine in CpG 7909 adjuvant SC on days 1, 21, 42, and 63 in the absence of unacceptable toxicity.
干预措施: tetanus-CMV fusion peptide vaccine (Biological)
Group B
Participants receive either PADRE-CMV fusion peptide vaccine in CpG 7909 adjuvant SC or tetanus-CMV fusion peptide vaccine in CpG 7909 adjuvant SC on days 1, 21, 42, and 63 in the absence of unacceptable toxicity.
干预措施: agatolimod sodium (Drug)
结局指标
主要结局
Maximum tolerated dose of each vaccine with or without adjuvant CpG 7909
时间窗: 1 year after the final vaccine dose
Successful completion of a series of 4 injections (at weeks 0, 3, 6, and 9) without dose-limiting toxicity
时间窗: 3 weeks after the final vaccine dose
次要结局
- Number of CMV-positive and CMV-specific CD8+ T cells/L(1 year after final vaccine dose)