A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of VXCO-100 in Healthy Adults in the United States
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 3
- 主要终点
- Number and percentage of participants with solicited local adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of ascending dose levels of VXCO-100 in healthy adults.
详细描述
This is a phase 1, multisite clinical trial to evaluate the safety and immunogenicity of 3 dose levels of VXCO-100 in healthy adult volunteers.
Participants will be vaccinated with 1 dose of VXCO-100 on Day 1. A subset of participants will be offered an optional interim boost at month 3.
Safety will be evaluated 1) before proceeding to a higher dose level and 2) prior to enrollment of participants aged 56 years and older at a particular dose level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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
研究组 & 干预措施
VXCO-100 Group 1
Participants 18-55 years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection
干预措施: VXCO-100 (Biological)
VXCO-100 Group 2
Participants 18-55 years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection
干预措施: VXCO-100 (Biological)
VXCO-100 Group 3
Participants 18-55 years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection
干预措施: VXCO-100 (Biological)
VXCO-100 Group 4
Participants 56+ years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection
干预措施: VXCO-100 (Biological)
VXCO-100 Group 5
Participants 56+ years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection
干预措施: VXCO-100 (Biological)
VXCO-100 Group 6
Participants 56+ years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection
干预措施: VXCO-100 (Biological)
结局指标
主要结局
Number and percentage of participants with solicited local adverse events
时间窗: For 7 days after each product administration
Number and percentage of participants with solicited systemic adverse events
时间窗: For 7 days after each product administration
Number and percentage of participants with unsolicited and safety laboratory-based adverse events
时间窗: For 28 days after each product administration
Numbers and percentages of participants with serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs)
时间窗: For up to 304 days after each product administration
次要结局
- Numbers and percentages of participants with positive Th1 or Th2 cytokine responses for CD4 and CD8 as measured by multi-parameter intracellular cytokine staining(At baseline and 7 days after each product administration)
- Response rate measured by geometric mean titer of the serum neutralizing antibody (Nab) against the ancestral (Wuhan) strain(At baseline and 21 days after each product administration)
- Response rate measured by GMT of Nab against selected variants of concern(At baseline and 21 days after each product administration)