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.

Trial Registration: NCT02019524

在这项随机的Ib期试验中，我们测试了将E39肽疫苗与从E39'（E39的减毒版）产生的疫苗相结合的过程。

接受标准护理治疗后无病的乳腺癌或卵巢癌患者，随机分为三组之一。Arm EE接受了六次E39接种；手臂EE'接受了3次E39'接种，随后进行了3次E39'接种；手臂E'E接受了3次E39'接种，其次是3次E39。在每组中，前五名患者接受500μg肽，其余患者接受1000μg。跟踪患者的毒性，并测量免疫反应。

初次接种疫苗系列完成后的初步分析已经确认了两种疫苗的安全性。免疫分析表明，掺入该肽的减毒版可改善免疫反应，而对E39进行测序，然后进行E39'测序可能会产生最佳的免疫反应。

试用注册：NCT02019524