Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, 1400 Pressler St, Unit 1484, Houston, TX 77030, United States.
Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 1155 Pressler St, Unit 1354, Houston, TX 77030, United States.
Clin Immunol. 2018 Jul;192:6-13. doi: 10.1016/j.clim.2018.03.010. Epub 2018 Mar 21.
In this randomized phase Ib trial, we tested combining the E39 peptide vaccine with a vaccine created from E39', an attenuated version of E39. Patients with breast or ovarian cancer, who were disease-free after standard of care therapy, were enrolled and randomized to one of three arms. Arm EE received six E39 inoculations; arm EE' received three E39 inoculations followed by three E39'; and arm E'E received three E39' inoculations, followed by three E39. Within each arm, the first five patients received 500 μg of peptide and the remainder received 1000 μg. Patients were followed for toxicity, and immune responses were measured. This initial analysis after completion of the primary vaccination series has confirmed the safety of both vaccines. Immune analyses suggest incorporating the attenuated version of the peptide improves immune responses and that sequencing of E39 followed by E39' might produce the optimal immune response.
NCT02019524.
在这项随机的 Ib 期试验中，我们检测了将 E39 肽疫苗与 E39'疫苗联合使用的效果，E39'疫苗是 E39 的减毒版本。经过标准治疗后无疾病的乳腺癌或卵巢癌患者被纳入并随机分配至以下三组中的一组。EE 组接受 6 次 E39 接种；EE'组接受 3 次 E39 接种后再接受 3 次 E39'；E'E 组接受 3 次 E39'接种后再接受 3 次 E39。每组中的前 5 名患者接受 500μg 肽，其余患者接受 1000μg。随访患者的毒性，测量免疫反应。在主要疫苗接种系列完成后的初始分析中，证实了两种疫苗的安全性。免疫分析表明，加入肽的减毒版本可改善免疫反应，并且按 E39 进行排序后再进行 E39'可能会产生最佳的免疫反应。
NCT02019524。
