CLINICAL TRIAL: LIPOPEPTIDE VACCINE WITH ACTIVITY AGAINST HUMAN CYTOMEGALOVIRUS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 本研究的目的是测试两种候选CMV疫苗，并确定这些疫苗的安全性和最佳剂量。尽管CMV感染在健康人中是一种罕见的问题，但对于免疫力低下的人来说，CMV感染仍然是一个问题。在未出生的婴儿中，巨细胞病毒是与智力低下有关的主要感染。此外，在移植受者中，CMV会导致严重的肺部感染，并可能导致自身免疫病患者失明。希望之城的研究人员发现，在人类对CMV的正常免疫反应中，可以识别一小段CMV，这种肽被称为“肽”，而且这种肽已经在小鼠实验中被证明是活跃的。一种疫苗已经被制造出来，在这种疫苗中，这种巨细胞病毒多肽被连接到一种称为“脂类”的化学物质上，这种化学物质有助于这种现在被称为“脂肽”的多肽作为疫苗发挥作用。此外，脂肽疫苗上还附着了一种提高免疫力的“帮手”肽。有两种疫苗(疫苗A和疫苗B)正在评估中，这两种疫苗含有相同的CMV肽但不同的辅助肽。还有两个疫苗试验：1)评估4个剂量水平的疫苗A和B对以前感染过CMV的人的安全性和免疫效果；以及2)评估基于安全性和免疫反应的较好的疫苗A或B对从未感染过CMV的志愿者的安全性和免疫效果。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to test two candidate CMV vaccines and to determine the safety and the optimal dose of these vaccines. CMV infection, although a rare problem in healthy people, continues to be a problem for persons with lowered immunity. In unborn babies, CMV is the leading infection linked to mental retardation. Also in transplant recipients CMV causes serious lung infection, and can cause blindness in Auto Immune Disease patients. Investigators at City of Hope have discovered that a small piece of CMV, called a "peptide", can be recognized during the normal human immune response to CMV, and this peptide has already been shown to be active in mice studies. A vaccine has been made in which this CMV peptide is attached to a chemical, called a "lipid", which helps the peptide, now called a "lipopeptide", to work as a vaccine. In addition, a "helper" peptide is also attached to the lipopeptide vaccine to improve immunity. There are two types of vaccine (vaccine A and vaccine B) being evaluated, and these have the same CMV peptide but different helper peptides. There are also two vaccination trials: 1) Evaluation of safety and immune effect of 4 dose levels of vaccine A and B in persons who have previously had a CMV infection; and 2) Evaluation of safety and immune effect of either vaccine A or B, whichever is better based on safety and immune response, in volunteers who have never had previous CMV infection.