A Randomized, Double-Blind Study to Evaluate a New Formulation of GEN-003 in Subjects With Genital HSV-2 Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 8
- 主要终点
- Change in HSV-2 viral shedding rate
研究概览
简要总结
This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.
详细描述
This study is a randomized, double-blind, placebo-controlled clinical trial of a new formulation of GEN-003 for treatment of HSV-2 genital infection.
Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals then complete a second set of anogenital swabs for 28 consecutive days after the third dose. Each subject will be followed for one year after the third dose.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection
干预措施: Placebo (Drug)
GEN-003 60ug / Matrix-M2 50ug
GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (50ug), administered as a 0.5mL intramuscular (IM) injection
干预措施: Matrix-M2 (Biological)
GEN-003 60ug / Matrix-M2 50ug
GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (50ug), administered as a 0.5mL intramuscular (IM) injection
干预措施: GEN-003 (Biological)
GEN-003 60ug / Matrix-M2 75ug
GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (75ug), administered as a 0.5mL intramuscular (IM) injection
干预措施: Matrix-M2 (Biological)
GEN-003 60ug / Matrix-M2 75ug
GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (75ug), administered as a 0.5mL intramuscular (IM) injection
干预措施: GEN-003 (Biological)
结局指标
主要结局
Change in HSV-2 viral shedding rate
时间窗: baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)
次要结局
- Immunogenicity measured by humoral (antibody) responses to vaccine antigens(13 weeks)
- Impact on clinical HSV-2 disease based on time to first recurrence(64 weeks)
- Number of patients with adverse events as a measure of safety and tolerability(64 weeks)
- Reduction in HSV-2 viral shedding rate(After vaccination (6 Months and 12 Months))
- Impact on clinical HSV-2 disease based on lesion rate(64 weeks)
- Impact on clinical HSV-2 disease based on percent recurrence-free(64 weeks)