drugset / Trial / NCT05069623
A Phase 1/2 Study to Determine Safety and Immunogenicity of Two COVID 19 Vaccines VB10.2129 (RBD Candidate) and VB10.2210 (T Cell Candidate) Previously Vaccinated in Healthy Adult Volunteers
Non-randomizedParallel-groupOpen-labelPrevention
Summary
An open label, dose escalation, and dose expansion study to evaluate the safety, reactogenicity and immunogenicity of two SARS-CoV-2 DNA plasmid vaccine candidates, VB10.2129 (C1) and VB10.2210 (C2). tThree dose levels will be tested. IM administrations 21 days apart. Part 1 is a dose escalation phase and Part 2 is a dose expansion phase. In Part 2 a selected dose will be tested further in additional healty volunteers.
Timeline
- Start
- 2021-11-01
- Primary completion
- 2022-12-16
- Completion
- 2023-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VB10.2129 | Unknown | 0.3 mg | Intramuscular |
| Subject | VB10.2129 | Unknown | 1 mg | Intramuscular |
| Subject | VB10.2129 | Unknown | 3 mg | Intramuscular |
| Subject | VB10.2210 | Unknown | — | Intramuscular |