CONTRACTOR: MAYO CLINIC; DUNNS: 006471700; PHASEI/II TRIAL OF A THERAPEUTIC DNA VACCINE FOR CHRONIC HEPATITIS C VIRUS (HCV) INFECTION;HHSN261201200042I; TASK ORDER HHSN26100006; 09/09/2014 09/08/2016

拟议的项目是一项I期临床试验，旨在评估治疗性丙型肝炎病毒(丙型肝炎病毒)DNA疫苗策略的安全性、耐受性和免疫原性，该策略将丙型肝炎病毒DNA疫苗与白细胞介素12相结合，并通过电穿孔给药。该试验旨在根据丙型肝炎病毒特异性细胞免疫反应(CD8T细胞产生干扰素γ和降低病毒载量)来确定疫苗免疫原性的最佳剂量。 具体地说，这项第一阶段试验将在4个时间点对慢性丙型肝炎患者测试候选疫苗，即编码非结构(NS)丙型肝炎病毒抗原(NS3/NS4A、NS4B和NS5A)的1a/1b型DNA疫苗，或在增加白介素12(IL-12)佐剂剂量的情况下测试该疫苗。 这项研究需要筛选32名参与者，大约需要22个月的时间来 为主要和次要终端招募并评估24名可评估参与者。

The proposed project is a phase I clinical trial designed to evaluate the safety, tolerability and immunogenicity of a therapeutic hepatitis C virus (HCV) DNA vaccine strategy that combines the HCV DNA vaccine with Interleukin-12 and is administered by electroporation. The trial aims to determine the optimal dose of IL-12 for vaccine immunogenicity based on induction of HCV-specific cellular immune responses (IFNγ production by CD8 T-cells and viral load reduction). Specifically, this Phase I trial will test the candidate vaccine, a genotype 1a/1b DNA vaccine encoding for non-structural (NS) HCV antigens (NS3 /NS4A, NS4B and NS5A) alone or with increasing doses of Interleukin 12 (IL-12) adjuvant, at 4 time points, to patients with chronic HCV. This study requires screening 32 participants and will take approximately 22 months to enroll and evaluate 24 evaluable participants for the primary and secondary endpoints.