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Dose-dependent effects of NY-ESO-1 protein vaccine complexed with cholesteryl pullulan (CHP-NY-ESO-1) on immune responses and survival benefits of esophageal cancer patients.


ABSTRACT: Cholesteryl pullulan (CHP) is a novel antigen delivery system for cancer vaccines. This study evaluated the safety, immune responses and clinical outcomes of patients who received the CHP-NY-ESO-1 complex vaccine, Drug code: IMF-001.Patients with advanced/metastatic esophageal cancer were enrolled and subcutaneously vaccinated with either 100 ?g or 200 ?g of NY-ESO-1 protein complexed with CHP. The primary endpoints were safety and humoral immune responses, and the secondary endpoint was clinical efficacy.A total of 25 patients were enrolled. Thirteen and twelve patients were repeatedly vaccinated with 100 ?g or 200 ?g of CHP-NY-ESO-1 with a median of 8 or 9.5 doses, respectively. No serious adverse events related to the vaccine were observed. Three out of 13 patients in the 100-?g cohort and 7 out of 12 patients in the 200-?g cohort were positive for anti-NY-ESO-1 antibodies at baseline. In the 100-?g cohort, an antibody response was observed in 5 out of 10 pre-antibody-negatives patients, and the antibody levels were augmented in 2 pre-antibody-positive patients after vaccination. In the 200-?g cohort, all 5 pre-antibody-negative patients became seropositive, and the antibody level was amplified in all 7 pre-antibody-positive patients. No tumor shrinkage was observed. The patients who received 200 ?g of CHP-NY-ESO-1 survived longer than patients receiving 100 ?g of CHP-NY-ESO-1, even those who exhibited unresponsiveness to previous therapies or had higher tumor burdens.The safety and immunogenicity of CHP-NY-ESO-1 vaccine were confirmed. The 200 ?g dose more efficiently induced immune responses and suggested better survival benefits. (Clinical trial registration number NCT01003808).

SUBMITTER: Kageyama S 

PROVIDER: S-EPMC4015172 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Dose-dependent effects of NY-ESO-1 protein vaccine complexed with cholesteryl pullulan (CHP-NY-ESO-1) on immune responses and survival benefits of esophageal cancer patients.

Kageyama Shinichi S   Wada Hisashi H   Muro Kei K   Niwa Yasumasa Y   Ueda Shugo S   Miyata Hiroshi H   Takiguchi Shuji S   Sugino Sahoko H SH   Miyahara Yoshihiro Y   Ikeda Hiroaki H   Imai Naoko N   Sato Eiichi E   Yamada Tomomi T   Osako Masaharu M   Ohnishi Mami M   Harada Naozumi N   Hishida Tadashi T   Doki Yuichiro Y   Shiku Hiroshi H  

Journal of translational medicine 20131005


<h4>Background</h4>Cholesteryl pullulan (CHP) is a novel antigen delivery system for cancer vaccines. This study evaluated the safety, immune responses and clinical outcomes of patients who received the CHP-NY-ESO-1 complex vaccine, Drug code: IMF-001.<h4>Methods</h4>Patients with advanced/metastatic esophageal cancer were enrolled and subcutaneously vaccinated with either 100 μg or 200 μg of NY-ESO-1 protein complexed with CHP. The primary endpoints were safety and humoral immune responses, and  ...[more]

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