A PHASE I TRIAL OF THE SAFETY AND IMMUNOGENICITY OF A DNA PLASMID BASED VACCINE (WOKVAC) ENCODING EPITOPES DERIVED FROM THREE BREAST CANCER ANTIGENS (IGFBP-2, HER2, AND IGF-IR) IN PAT

PAT 中编码源自三种乳腺癌抗原（IGFBP-2、HER2 和 IGF-IR）表位的 DNA 质粒疫苗 (WOKVAC) 的安全性和免疫原性的 I 期试验

• 批准号: 9552662
• 负责人: HOWARD BAILEY
• 金额: $ 25.16万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9552662
• 关键词: Address; Antigens; Breast Cancer Prevention; Clinical; Clinical Trials; DNA; Disease remission; Dose; ERBB2 gene; Epitopes; Image; Insulin-Like Growth-Factor-Binding Proteins; Mammographic Density; Myelogenous; No Evidence of Disease; Operative Surgical Procedures; Patients; Phase; Plasmids; Positive Lymph Node; Regulatory T-Lymphocyte; Safety; Suppressor-Effector T-Lymphocytes; T memory cell; Vaccination; Vaccines; base; immunogenicity; malignant breast neoplasm; phase I trial; response

The proposed clinical trial will address safety and immunogenicity of a DNA Plasmid Based Vaccine (WOKVAC) Encoding Epitopes Derived From Three Breast Cancer Antigens (IGFBP-2, HER2, and IGF-1R). It is a pre-surgical phase I dose-escalation study in patients with non-metastatic, node positive, HER2 negative breast cancer that is in remission and defined as no evidence of disease (NED).

拟议的临床试验将讨论基于DNA质粒的疫苗（WOKVAC）的安全性和免疫原性，该疫苗编码源自三种乳腺癌抗原（IGFBP-2、HER 2和IGF-1 R）的表位。 这是一项在缓解期且定义为无疾病证据（NED）的非转移性、淋巴结阳性、HER 2阴性乳腺癌患者中进行的术前I期剂量递增研究。