drugset / Trial / NCT05197712
Evaluation of the Safety, Tolerability, and Reactogenicity of the Baiya SARS-CoV-2 Vax 2 Vaccine for COVID-19 Disease
Phase 1
Unknown
24 enrolled
Baiya Phytopharm Co., Ltd.
National Vaccine Institute, Thailand · collab
Non-randomizedSequentialOpen-labelPrevention
Summary
The investigational product Baiya SARS-CoV-2 Vax 2 vaccine is a second-generation of protein subunit vaccine from plant. The primary objective aiming to evaluate the safety, tolerability, and reactogenicity of Baiya SARS-CoV-2 Vax 2 in adults (aged between 18 to 64 years, inclusive) after 2 doses of Baiya SARS-CoV-2 Vax 2 given 21 days apart IM, up to 28 days after the second vaccination. The secondary objective aiming to evaluate long-term safety profile (up to 1 year) and evaluate immunogenicity after 2 doses of Baiya SARS-CoV-2 Vax 2 given 21 days apart.
Timeline
- Start
- 2022-03-28
- Primary completion
- 2023-05-29
- Completion
- 2024-04-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baiya SARS-CoV-2 Vax 2 | Vaccine | 25 ug | Intramuscular |
| Subject | Baiya SARS-CoV-2 Vax 2 | Vaccine | 50 ug | Intramuscular |
Indications
No indication recorded.