CLINICAL TRIAL: LIPOPEPTIDE VACCINE WITH ACTIVITY AGAINST HUMAN CYTOMEGALOVIRUS

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者的研究机构。 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。 CMV感染，虽然在健康人群中是一个罕见的问题，但对于免疫力低下的人来说仍然是一个问题。 在未出生的婴儿中，CMV是与智力迟钝有关的主要感染。 在移植受者中，CMV也会引起严重的肺部感染，并可能导致艾滋病患者失明。 City of Hope的研究人员发现，在正常的人类对CMV的免疫反应中，可以识别出一小块CMV，称为“肽”，并且这种肽已经在小鼠研究中显示出活性。 已经制造出一种疫苗，其中这种CMV肽与一种称为“脂质”的化学物质连接，这有助于这种肽（现在称为“脂肽”）作为疫苗发挥作用。 此外，脂肽疫苗上还附着了一种“辅助”肽，以提高免疫力。 有两种类型的疫苗（疫苗A和疫苗B）正在评估，这些疫苗具有相同的CMV肽，但具有不同的辅助肽。 还有两项疫苗接种试验：1）在既往有CMV感染的人群中评价4种剂量水平的疫苗A和B的安全性和免疫效果; 2）在既往无CMV感染的志愿者中评价疫苗A或B的安全性和免疫效果，以安全性和免疫应答更好者为准。

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 AIDS 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.