A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1/2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 Therapeutic DNA Vaccines in Symptomatic HSV-2-Seropositive Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Vical
- 入组人数
- 165
- 试验地点
- 14
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of two experimental therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).
详细描述
This is a dose escalation study to evaluate the safety, immunogenicity, and efficacy of 3 doses of HSV plasmid DNA (pDNA) vaccines formulated with Vaxfectin® in subjects with a minimum of 1 year of reported history of genital herpes, and either 2 to 9 recurrences within the year prior to screening, or 2 to 9 recurrences per year prior to starting suppressive therapy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HSV-2 seropositive
- •A minimum of 1 year of reported history of genital herpes and either 2 to 9 recurrences within the year prior to screening or 2 to 9 recurrences per year prior to starting suppressive therapy
排除标准
- •History of receiving an investigational HSV vaccine
- •Chronic illness for which a subject's immune system is suspected to be impaired or altered, such as cancer, autoimmune conditions, or diabetes
- •Pregnant or breastfeeding
研究组 & 干预措施
PBS, 1-mL dose
PBS, 1-mL dose by intramuscular injection once every 28 days for 3 doses
干预措施: PBS (Biological)
VCL-HB01, 0.25-mL dose
VCL-HB01, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses
干预措施: VCL-HB01 (Biological)
VCL-HM01, 1-mL dose
VCL-HM01, 1-mL dose by intramuscular injection once every 28 days for 3 doses
干预措施: VCL-HM01 (Biological)
PBS, 0.25-mL dose
PBS, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses
干预措施: PBS (Biological)
PBS, 0.5-mL dose
PBS, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses
干预措施: PBS (Biological)
VCL-HB01, 0.5-mL dose
VCL-HB01, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses
干预措施: VCL-HB01 (Biological)
VCL-HB01, 1-mL dose
VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 3 doses
干预措施: VCL-HB01 (Biological)
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to Day 420
Viral shedding rate change from baseline
时间窗: Baseline, Day 150
次要结局
- Genital lesion rate change from baseline(Baseline, Day 150)
- HSV DNA copy numbers change from baseline(Baseline, Day 150)
- Genital recurrence rate compared with placebo(Up to Day 330)
- Subclinical genital shedding rate change from baseline(Up to Day 150)
- T-cell and/or antibody responses change from baseline(Baseline, Days 7, 35, 63, 150, 330)