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

临床试验：活性肽疫苗的 I 期剂量递增研究

• 批准号: 7982075
• 负责人: John A Zaia
• 金额: $ 43.6万
• 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/7982075
• 关键词: Adjuvant; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cytomegalovirus; Dose; Funding; Grant; Institution; Peptide Vaccines; Peptides; Phase; Research; Research Personnel; Resources; Safety; Sodium Acetate; Sodium Bicarbonate; Source; Staging; Tetanus; United States National Institutes of Health; Vaccines; immunogenicity

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.

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所在的机构。 这是一项关于两种巨细胞病毒CMV肽疫苗（称为PADRE-CMV和Tetanus-CMV）的I期剂量递增研究，将在两个伴随阶段分别进行：试验A将评价疫苗肽加10 mM醋酸钠（pH 4.2）/4.0%碳酸氢钠（pH 8.0）溶剂的安全性主要终点和免疫原性次要终点。 试验B将评价疫苗肽加媒介物加CpG佐剂的安全性主要终点和免疫原性次要终点。 由于肽疫苗的每个剂量水平在试验A中安全完成，因此将在试验B中评价相同的剂量水平。