A Phase 1, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Immunogenicity of the bacTRL-Spike Oral Candidate Vaccine for the Prevention of COVID-19 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Frequency of Adverse Events
研究概览
简要总结
Protocol bacTRL-Spike-1 will be the first-in-human study of bacTRL-Spike, and the first-in-human use of orally delivered bacTRL. Each oral dose of bacTRL-Spike contains bacterial medium with either 1 billion (Group 1A), 3 billion (Group 2A) or 10 billion (Group 3A) colony-forming-units of live Bifidobacterium longum, which has been engineered to deliver plasmids containing synthetic DNA encoding spike protein from SARS-CoV-2.
详细描述
Protocol bacTRL-Spike-1 will be the first-in-human study of bacTRL-Spike, and the first-in-human use of orally delivered bacTRL. The trial is designed to evaluate the safety and tolerability of orally delivered bacTRL-Spike vaccine in healthy adults.
Total anticipated enrollment is n=24. The distribution of the sample size will be as follows:
- Group 1 (n=3; Sentinel +2): Single dose of bacTRL-Spike, equivalent to 1 billion colony forming units (cfu) of Bifidobacterium longum (B. longum);
- Group 2 (n=3; Sentinel +2): Single dose of bacTRL-Spike, equivalent to 3 billion cfu of B. longum;
- Group 3 (n=3; Sentinel +2): Single dose of bacTRL-Spike, equivalent to 10 billion cfu of B. longum;
- Group 4 (n=3): Single Data and Safety Monitoring Board (DSMB)-defined dose of bacTRL-Spike among subjects 56 years of age and older.
- Group 5 (n=12): DSMB-defined prime and boost doses of bacTRL-Spike delivered with a 28-day intervening interval.
The planned trial duration is 18 months.
Each participant will remain in the trial for 12-13 months, including a screening phase of up to 28 days, intervention phase of 1 day and follow-up phase of 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
结局指标
主要结局
Frequency of Adverse Events
时间窗: Up to12 months post-vaccination
Adverse events (specifically including incidence of gastrointestinal-associated events) following administration of oral bacTRL-Spike
次要结局
- bacTRL-Spike in stool post-vaccination(Days 8, 15, 22, and 1 and 3 months post-vaccination)
- Immune response against SARS-CoV-2 Spike protein(Baseline (pre-vaccination), and 1, 3 and 12 months post-vaccination)
- Incidence of COVID-19 infection(Up to 12 months post-vaccination)
- Immunity against SARS-CoV-2(Up to 12 months post-vaccination)