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Cancer Vaccine with NY-ESO-1 Protein as Adjuvant Therapy after Surgical Treatment

含有 NY-ESO-1 蛋白的癌症疫苗作为手术治疗后的辅助治疗

基本信息

批准号：
17390366
负责人：
DOKI Yuichiro
金额：
$ 9.73万
依托单位：
Osaka University
依托单位国家：
日本
项目类别：
Grant-in-Aid for Scientific Research (B)
财政年份：
2005
资助国家：
日本
起止时间：
2005 至 2006
项目状态：
已结题

来源：
https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-17390366/
关键词：
NY-ESO-1 cancer vaccine immune therapy esophageal cancer adjuvant therapy tumor-free survival rate tumor specific antigen 癌抗原術後アジュバント蛋白免疫

项目摘要

We performed the Phase I clinical trial "Cancer vaccine with NY-ESO-1 protein against advanced esophageal cancer patients." 13 patients were entered, and advanced effects, immune responses and clinical responses by the reagent were observed. No severe advanced effect was observed. For NY-ESO-1 specific immune responses antibody and CD4, CD8 T cells were analyzed by ELISA and secretion assay of INF-gamma, respectively. Remarkable or local clinical responses were observed in 4 out of 13 patients and they showed both elevation of antibody titer and detectable induction of CD4 T cells. CD8 T cells were observed in most of patients. Epitopes of antibody, CD4 and CD8 T cells in NY-ESO-1 protein were analyzed and we identified high immunogenic lesion with about 70 amino acids long at the center of NY-ESO-1 protein sequence, which were easily and economically producible by the Peptide Synthesizer without use of E. Coli. Instead of whole protein, this high immnogenic 70-mer peptide is being synthesized for the "Cancer Vaccine with NY-ESO-1 Protein as Adjuvant Therapy after Surgical Treatment for esophageal cancer patients."For this trial, advanced esophageal cancer patients will be vaccinated as the adjuvant therapy after curative surgical treatment with pre-operative chemotherapy. We have already calculated the tumor-free survival rate of those 60 patients as a control. Performing the trial new control patients will be recruited accumulated on this control.We also plan to vaccine with overlapping serial short peptides from NY-ESO-1 sequence.

我们进行了NY-ESO-1蛋白肿瘤疫苗治疗晚期食道癌的I期临床试验，共纳入13例患者，观察该试剂的晚期疗效、免疫应答和临床反应。未观察到严重的进展性反应。采用酶联免疫吸附试验检测NY-ESO-1特异性免疫应答抗体，用干扰素-γ分泌法检测CD4、CD8T细胞。13例患者中有4例出现显著或局部临床反应，表现为抗体滴度升高和可检测到的CD4T细胞诱导。大多数患者可见CD8T细胞。对NY-ESO-1蛋白的抗体表位、CD4和CD8T细胞表位进行了分析，发现NY-ESO-1蛋白序列的中心有70个氨基酸左右的高免疫原性损伤，这种多肽合成器无需使用E.Coli就可以方便、经济地生产NY-ESO-1蛋白。这种高免疫原性的70多肽不是全蛋白，而是正在合成的，用于“以NY-ESO-1蛋白作为食道癌手术后辅助治疗的癌症疫苗”。在这次试验中，晚期食道癌患者将在根治性手术治疗后接种疫苗作为手术前化疗的辅助治疗。我们已经计算了这60名患者的无瘤存活率作为对照。在进行试验时，将招募在该对照上积累的新的对照患者。我们还计划用来自NY-ESO-1序列的重叠序列短肽进行疫苗接种。