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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是 2 种巨细胞病毒 (CMV) 肽疫苗（称为 PADRE-CMV 和破伤风-CMV）的 I 期剂量递增研究，将分两个同时进行的阶段分别进行：试验 A 将评估疫苗（肽加 10mM 乙酸钠载体，pH 4.2/4.0% 碳酸氢钠，pH 8.0）的安全性（主要终点）和 免疫原性（次要终点）。 试验 B 将评估疫苗（肽加载体加 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都在试验 A 中安全完成，因此相同的剂量水平将在试验 B 中进行评估。