drugset / Trial / NCT04334980
Evaluating the Safety, Tolerability and Immunogenicity of bacTRL-Spike Vaccine for Prevention of COVID-19
NaSingle-groupOpen-labelPrevention
Summary
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.
Timeline
- Start
- 2020-11-02
- Primary completion
- 2022-08-31
- Completion
- 2022-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | bacTRL-Spike | Vaccine | 1e+09 cells | Oral |
| Subject | bacTRL-Spike | Vaccine | 3e+09 cells | Oral |
| Subject | bacTRL-Spike | Vaccine | 1e+10 cells | Oral |