A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine
Summary
Part 1: An open label, dose and age escalation phase to evaluate the safety and immunogenicity of VXA-CoV2-1.1-S with a repeat-dose vaccination schedule in healthy adults aged 18 - 75 years old that are either vaccine naive or have received prior vaccination with an mRNA (messenger ribonucleic acid) vaccine for the prevention of COVID-19. Part 2: This phase will assess the efficacy of prophylactic VXA-CoV2-1.1-S against confirmed COVID-19 occurring from 7 days after second dose with a repeat-dose vaccination schedule in healthy adults compared to placebo. Safety and immunogenicity of VXA-CoV2-1.1-S will also be evaluated in this phase.
Timeline
- Start
- 2021-10-22
- Primary completion
- 2022-06-10
- Completion
- 2023-05-09
Outcome
Met primary endpoint
Stopped: “The study drug was no longer available.”
release “The data demonstrate that the trial met its primary safety and secondary immunogenicity endpoints” vaxart.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VXA-CoV2-1.1-S | Vaccine | — | Oral |