drugset / Trial / NCT04685603
Dendritic Cell Vaccine to Prevent COVID-19
Phase 1
Unknown
27 enrolled
Indonesia-MoH
Aivita Biomedical, Inc. · collabFaculty of Medicine University of Diponegoro, Indonesia · collabNational Institute of Health Research and Development, Ministry of Health Republic of Indonesia · collabPT AIVITA Biomedika Indonesia · collabRSUP Dr. Kariadi Semarang, indonesia · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This is an adaptive Phase I 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
- 2020-12-07
- Primary completion
- 2021-01-31
- Completion
- 2022-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AV-COVID-19 | Vaccine | 0.1 mg | Subcutaneous |
| Subject | AV-COVID-19 | Vaccine | 0.33 mg | Subcutaneous |
| Subject | AV-COVID-19 | Vaccine | 1 mg | Subcutaneous |