Phase I Study of the Safety, Tolerability and Immunogenicity of GLS-5310 DNA Vaccine Against SARS-CoV-2
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Geometric mean titer (GMT) of antigen specific antibody titers
研究概览
简要总结
Phase I study of the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2 (COVID-19)
详细描述
This Phase I, randomized, placebo-controlled, dose-ranging, single-blind study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine administered intradermally (ID) with or without concomitant intranasal (IN) administration of GLS-5310. Vaccine delivered ID will either be performed by Mantoux injection and followed by suction applied to the skin surface using the Gene-Derm device or Mantous injection alone without applied suction. Vaccine delivered IN will be administered using the MAD300 atomizer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Geometric mean titer (GMT) of antigen specific antibody titers
时间窗: Through 56 weeks post vaccination
Endpoint titer of binding antibody in serum
Incidence of adverse events
时间窗: Through 56 weeks post vaccination
solicited/unsolicited local and systemic AEs
次要结局
- Evaluation of positive response rate of T cell responses induced by GLS-5310(Through 56 weeks post vaccination)
- Geometric mean titer (GMT) of neutralizing antibody titers(Through 56 weeks post vaccination)