Clinical trial of cancer vaccine using NY-ESO-1/CpG

本研究的目的是阐明肿瘤抗原NY-ESO-1在癌症患者中的表达状况以及NY-ESO-1表达肿瘤患者的癌症疫苗接种的安全性。首先，我们构建了免疫组织化学（IHC）的阳性对照和阴性对照，以筛选NY-ESO-1的基因表达。RT-PCR检测表明，HEC 46为NY-ESO-1阳性，TE 8阴性。将这些细胞系皮下植入SCID小鼠，并切除肿瘤。制作石蜡包埋切片，并确认IHC的适当条件。NY-ESO-1表达分析。122例食管鳞状细胞癌（ESCC）患者的IHC。NY-ESO-1阳性的晚期食管鳞癌患者的预后明显好于NY-ESO-1阴性的晚期食管鳞癌患者。此外，NY-ESO-1的表达与浸润的CD 4 +T细胞和CD 8 +T细胞的数量显着相关。因此，NY-ESO-1的表达将诱导ESCC患者的宿主的抗肿瘤免疫。随后，进行了使用NY-ESO-1和CpG的癌症疫苗接种的临床试验。该试验的目的是阐明该疗法的安全性。1例乳腺癌患者入组本试验，并尝试了3次疫苗接种。未观察到副作用，也未证实临床获益。

The purpose of this study is to clarify the status of tumor antigen NY-ESO-1 expression in patients with cancer and the safety of cancer vaccination for patients with NY-ESO-1 expressing tumor. Initially, we constructed a positive control and a negative control for immunohistochemistry (IHC) to screen gene expression of NY-ESO-1. RT-PCR identified that HEC46 was NY-ESO-1 positive and TE8 negative. These cell lines were implanted into SCID mice subcutaneously and the tumors were resected. Paraffin embedded sections were made and appropriate condition of IHC was confirmed. NY-ESO-1 expression was analyzed by. IHC in 122 patients with esophageal squamous cell carcinoma (ESCC). The prognosis of patients with advanced ESCC expressing NY-ESO-1 was significantly better than that of patients with NY-ESO-1 negative tumor. Moreover, NY-ESO-1 expression was significantly correlated to the number of infiltrating CD4+T cells and CD8+T cells. Therefore, NY-ESO-1 expression would induce anti-tumor immunity of the host in patients with ESCC. Subsequently, clinical trial of cancer vaccination using NY-ESO-1 and CpG was performed. The purpose of the trial was to clarify the safety of the therapy. A patient with breast cancer was entered this trial and vaccinations were tried tree times. No side effect was observed and no clinical benefit was confirmed.