Phase I/II Study to Evaluate Safety, Tolerability, and Immunogenicity of a Prophylactic Plasmid DNA Vaccine Against SARS-CoV-2 [Covigenix VAX-001/VAX-001-1b] in Healthy Adults 18 Years and Older
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 6
- 主要终点
- Safety of a 2-dose regimen of VAX-001 when doses are given 14 days apart
研究概览
简要总结
This study is a Phase I/II clinical study in healthy adults designed to assess the safety, tolerability, and immunogenicity of receiving 2 IM injections of Covigenix VAX-001/-1b, 28 days apart. Covigenix VAX-001/-1b is a plasmid DNA vaccine that expresses key antigenic determinants from SARS-CoV-2 and uses Entos Pharmaceuticals' Fusogenix PLV platform.
The phase I part of this study was completed in Canada. The phase II part of the study will be completed in Burkina Faso, Senegal and South Africa.
详细描述
Phase I portion of the study:
Study design:
ENTVAX01-101 is a phase I/II, placebo-controlled, randomized, observer-blind, dose ranging clinical trial in males and non-pregnant females, 18 years and older, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, tolerability, and immunogenicity of Covigenix VAX-001 manufactured by Entos Pharmaceuticals. Covigenix VAX-001 is a novel plasmid DNA-based vaccine that encodes for the full-length Spike protein from SARS-CoV-2 (VAX-001 encapsulated in a proprietary Fusogenix Proteo-Lipid Vehicle (PLV)).
Enrollment for the phase I portion of the study will occur at one Canadian site. Thirty-six participants will be enrolled in a staggered manner into one cohort an 3 groups (0.100 mg & 0.250 mg vs. placebo) in stage I. Participants will receive an intramuscular (IM) injection (0.5 milliliter [mL]) on Days 0 and 14 in the deltoid muscle of alternating arms and will be followed through 12 months post booster vaccination (Day 379). Follow-up visits will occur at Days 7, 14, 17, 21, 28, 42, 196, and 379.
The primary objective is to evaluate the safety of a 2-dose vaccination schedule of the Covigenix VAX-001 vaccine, given 14 days apart. The secondary objectives are to evaluate the humoral immune response as measured by Immunoglobulin G (IgG) ELISA to the SARS-CoV-2 S protein and by pseudo-viral neutralization assay to pseudo-virion following a 2-dose vaccination schedule of Covigenix VAX-001.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Unblinded study nurse with no other role in the trial administers VAX-001. Observer blinded.
入排标准
- 年龄范围
- 18 Years 至 95 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
研究组 & 干预措施
Placebo
Placebo injection. 12 subjects receiving placebo
干预措施: Covigenix VAX-001 placebo (Biological)
结局指标
主要结局
Safety of a 2-dose regimen of VAX-001 when doses are given 14 days apart
时间窗: Day 0 - 42
Frequency and Grade (mild, moderate, severe, potentially life-threatening; Gr. 1-4, respectively) of solicited injection site and systemic adverse events and unsolicited systemic adverse events
Mean change from baseline in safety laboratory measures
时间窗: Day 0 - 42
Adverse hematology /clinical chemistry parameter changes (mild, moderate, severe, or life-threatening; Gr. 1-4, respectively)
Frequency of treatment-emergent Serious Adverse Events (SAE) throughout the study and up to 12 months post-second dose immunization (Day 379).
时间窗: Day 0 - 379
Frequency of serious AEs
次要结局
- Persistence of IgG antibody titers as measured by ELISA and neutralizing antibody titers measured by pseudo-virion neutralization assay, six months after the second vaccine dose(Up to Day 379)
- Percent seroconversion defined as a 4-fold or greater increase in IgG titers after one or two doses as measured by IgG ELISA(Up to Day 379)
- Percent seroconversion defined as a 4-fold or greater increase in IgG titers after one or two doses as measured by pseudo-viral neutralization assay.(up to Day 379)
- Geometric mean neutralizing antibody titers against pseudo-virion after one and two doses(Up to Day 379)