SAFETY AND IMMUNOLOGICAL EVALUATION OF NY-ESO-1 PLASMID DNA (PPJV7611) CANCER

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项针对表达NY-ESO-1的NSCLC患者的研究有望证明：1)PMED给药的NY-ESO-1质粒DNA （pPJV7611）癌症疫苗可以安全使用，以治疗相关不良反应的频率、严重程度和持续时间为终点；2)通过检测NY-ESO-1特异性抗体、NY-ESO-1特异性CD8+和CD4+细胞以及延迟型超敏感[DTH]，疫苗引发了对NY-ESO-1的细胞和体液免疫应答。3)记录可测量疾病患者接受PMED给药的NY-ESO-1质粒DNA （pPJV7611）癌症疫苗后的肿瘤反应。

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 study in the targeted populaton of NSCLC patients expressing NY-ESO-1 expected to demonstrate that 1) NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine given by PMED can be safely administered using frequency, severity, and duration of treatment-related adverse effects as endpoints, 2) the vaccine elicits a cellular and humoral immune response to NY-ESO-1 by determination of NY-ESO-1 specific antibody, NY-ESO-1 specific CD8+ and CD4+ cells and delayed-type-hypersensitivity [DTH], and 3) to document tumor response in patients with measurable disease after receiving NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine administered by PMED.