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

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。子项目及 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。 本研究在表达NY-ESO-1的NSCLC患者的目标人群中进行，预期将证明：1）NY-ESO-1质粒DNA（pPJV 7611）通过PMED给予的癌症疫苗可以使用与治疗相关的不良反应的频率、严重性和持续时间作为终点安全地施用，2）通过测定NY-ESO-1特异性抗体，疫苗增强对NY-ESO-1的细胞和体液免疫应答，NY-ESO-1特异性CD 8+和CD 4+细胞和迟发型超敏反应[DTH]，和3）记录接受PMED给予的NY-ESO-1质粒DNA（pPJV 7611）癌症疫苗后患有可测量疾病的患者的肿瘤应答。

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.