drugset / Trial / NCT04386252
Phase I-II Trial of Dendritic Cell Vaccine to Prevent COVID-19 in Adults
Non-randomizedSequentialOpen-labelPrevention
Summary
This is an adaptive Phase I-II trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.
Timeline
- Start
- 2023-01
- Primary completion
- 2023-06
- Completion
- 2024-01
Outcome
Outcome not reported
Stopped: “The FDA put our protocol on clinical hold and never gave an okay to start, so we decided not to proceed”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AV-COVID-19 | Vaccine | 0.1 ug | Subcutaneous |
| Subject | AV-COVID-19 | Vaccine | 0.33 ug | Subcutaneous |
| Subject | AV-COVID-19 | Vaccine | 1 ug | Subcutaneous |