CLINICAL TRIAL: LIPOPEPTIDE VACCINE WITH ACTIVITY AGAINST HUMAN CYTOMEGALOVIRUS

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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.