医学
离体
加药
体内
佐剂
HER2/东北
肽疫苗
癌症疫苗
乳腺癌
药理学
肿瘤科
免疫学
免疫疗法
癌症
免疫原性
临床试验
内科学
免疫系统
抗原
表位
生物
生物技术
作者
Linda C. Benavides,Alan K. Sears,Jeremy D. Gates,Guy T. Clifton,Kevin S. Clive,Mark G. Carmichael,Jarrod P. Holmes,Elizabeth A. Mittendorf,Sathibalan Ponniah,George E. Peoples
摘要
We have performed multiple adjuvant clinical trials using immunogenic peptides from the HER2/neu protein (AE37/E75/GP2) plus (GM-CSF) given intradermally to breast cancer patients. Four trials were performed with similar dose-escalation design with increasing doses of peptide (AE37/E75/GP2) and varying amounts of GM-CSF. Dose reductions (DRs) were made for significant local and/or systemic toxicity by decreasing GM-CSF for subsequent inoculations. Ex vivo and in vivo immunologic responses were used to compare groups. Of 132 patients, 39 required DR (30 for robust local reactions [DR-L]). DR patients, particularly DR-L, had greater immune responses both ex vivo and in vivo. Postvaccine delayed-type hypersensitivity in DR-L patients compared with all others was larger for E75 (p = 0.001), AE37 (p = 0.077) and GP2 (p = 0.076). All three peptide vaccines were safe and well-tolerated. These findings have led to a clinically relevant optimal vaccine dosing strategy, which may be applicable to other peptide-based cancer vaccines.
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