CLINICAL TRIAL: LIPOPEPTIDE VACCINE WITH ACTIVITY AGAINST HUMAN CYTOMEGALOVIRUS

临床试验：具有抗人类巨细胞病毒活性的脂肽疫苗

• 批准号: 7982051
• 负责人: Don J Diamond
• 金额: $ 37.07万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7982051
• 关键词: Acquired Immunodeficiency Syndrome; Blindness; Chemicals; Cities; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cytomegalovirus; Cytomegalovirus Vaccines; Dose; Evaluation; Funding; Grant; Human; Immune; Immune response; Immunity; Infection; Institution; Link; Lipids; Lung; Mental Retardation; Mus; Patients; Peptides; Persons; Research; Research Personnel; Resources; Safety; Source; Testing; Transplant Recipients; United States National Institutes of Health; Vaccination; Vaccines; Work; base; improved; prenatal; volunteer

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项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感染虽然在健康人中是一个罕见的问题，但对于降低免疫力的人来说仍然是一个问题。 在未出生的婴儿中，CMV是与智力低下有关的主要感染。 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。 希望之城的研究人员发现，在正常的人类免疫反应中，可以识别出一小部分称为“肽”的CMV，并且已经证明该肽在小鼠研究中是活跃的。 已经进行了一种疫苗，该疫苗将这种CMV肽连接到一种称为“脂质”的化学物质上，该化学物质有助于肽，现在称为“脂蛋白肽”，以作为疫苗作用。 另外，“辅助”肽还附着在脂肽疫苗上以提高免疫力。 评估了两种类型的疫苗（疫苗A和疫苗B），它们具有相同的CMV肽，但辅助肽不同。 还有两项疫苗接种试验：1）对以前感染CMV感染的人的4剂水平A和B的安全性和免疫作用的评估； 2）评估疫苗A或B的安全性和免疫作用，以安全性和免疫反应更好，以前从未感染过CMV感染的志愿者。