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

针对慢性丙型肝炎病毒 (HCV) 感染的治疗性 DNA 疫苗的第二阶段试验；

• 批准号: 9918807
• 负责人: PAUL J LIMBURG
• 金额: $ 8.47万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-09 至 2021-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9918807
• 关键词: Adjuvant; Antibody Response; CD4 Positive T Lymphocytes; CD8-Positive T-Lymphocytes; CD8B1 gene; Chronic Hepatitis C; Clinical Trials Design; DNA Vaccines; Dose; Electroporation; Enrollment; Evaluable Disease; Genotype; Hepatitis C Therapy; Hepatitis C virus; Immune response; Interferon Type II; Interleukin-12; Participant; Patients; Phase I Clinical Trials; Production; Safety; Testing; Time; Vaccines; Viral Antigens; Viral Load result; base; immunogenicity; phase I trial; plasmid DNA; primary endpoint; response; screening; secondary endpoint; therapeutic DNA; vaccine candidate; viral RNA; virology

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.

拟议的项目是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疫苗与白介素-12结合在一起，并通过电穿孔施用。该试验旨在根据诱导HCV特异性细胞免疫调查剂（通过CD8 T细胞产生IFNγ和降低病毒载荷），确定IL-12的最佳剂量用于疫苗免疫原性。 具体而言，该阶段试验将测试候选疫苗，这是一种编码非结构性（NS）HCV抗原（NS3 /NS4A，NS4B和NS5A）的基因型1A /1B DNA疫苗，或者在4个时间点（IL-12）调整剂量的剂量增加，以摄取4个时间点（IL-12）患者，以调整chornicpots，或者在4个时间内调整剂量。 这项研究需要筛选32名参与者，大约需要22个月 注册和评估24个评估参与者的主要和次要终点。