CLINICAL TRIAL: A PHASE I DOSE ESCALATION STUDY OF PEPTIDE VACCINES WITH ACTIVIT

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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. This a Phase I dose-escalation study of 2 cytomegalovirus (CMV) peptide vaccines (called PADRE-CMV and Tetanus-CMV) that will be performed separately in two concomitant stages: Trial A will evaluate the vaccines (peptide plus vehicle of 10mM sodium acetate, pH 4.2/4.0% sodium bicarbonate, pH 8.0) for safety (primary endpoint) and immunogenicity (secondary endpoint). Trial B will evaluate the vaccines (peptide plus vehicle plus CpG adjuvant) for safety (primary endpoint) and immunogenicity (secondard endpoint). As each dose level for a peptide vaccine is safely completed in Trial A, that same dose level will be evaluated in Trial B.