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

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。 这是一项名为Padre-CMV和破伤风-CMV的两种巨细胞病毒多肽疫苗的I期剂量递增研究，将分两个伴随阶段分别进行：试验A将评估疫苗+10 mM醋酸钠、pH 4.2/4.0%碳酸氢钠、pH 8.0和#41；的安全性和免疫原性。试验B将评估疫苗、多肽、赋形剂和CpG佐剂的安全性、主要终点和免疫原性。由于多肽疫苗的每个剂量水平在试验A中安全完成，同样的剂量水平将在试验B中进行评估。

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.