NCT05841095进行中（未招募）1 期
Phase I/II Study to Determine the Safety, Immunogenicity and Efficacy of the Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Safety according to AEs, SAEs
研究概览
简要总结
The goal of this clinical trial is to test ISA104 in patients with chronic hepatitis B. The main question[s] it aims to answer are:
- How safe is ISA104?
- Does ISA104 induce immunity against hepatitis B virus?
Different doses of the vaccine ISA104 will be administered to participants. These participants are chronic HBV patients being actively treated with antiviral drugs.
Researchers will compare the ISA104 vaccine to a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active treatment with NUCs and HBV DNA < limit of quantification
排除标准
- •Immune-compromised
- •Evidence of liver cirrhosis
研究组 & 干预措施
ISA104
Active Comparator
干预措施: ISA104 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety according to AEs, SAEs
时间窗: 6 months
AEs, SAEs
次要结局
- HBV specific Immunogenicity- following ISA104 vaccination(6 months)
- Efficacy of ISA104 vaccination by using conventional biomarkers(6 monts)
研究者
Dave Sprengers
Priniciple Investigator, MD PhD
Erasmus Medical Center
研究点 (2)
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