PHASEI/II TRIAL OF A THERAPEUTIC DNA VACCINE FOR CHRONIC HEPATITIS C VIRUS (HCV) INFECTION;

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（HCV）DNA疫苗策略的安全性，耐受性和免疫原性，该策略将HCV DNA疫苗与白细胞介素-12结合，并通过电穿孔进行给药。该试验旨在根据HCV特异性细胞免疫应答的诱导（CD 8 T细胞产生IFNγ和病毒载量降低）确定疫苗免疫原性的IL-12最佳剂量。 具体而言，该I期试验将在4个时间点对慢性HCV患者测试候选疫苗，即编码非结构（NS）HCV抗原（NS 3/NS 4A，NS 4 B和NS 5A）的基因型1a/1b DNA疫苗，或与增加剂量的白细胞介素12（IL-12）佐剂一起使用。 这项研究需要筛选32名参与者，将需要大约22个月的时间， 招募并评估24名可评估参与者的主要和次要终点。

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.