drugset / Trial / NCT05197712

Evaluation of the Safety, Tolerability, and Reactogenicity of the Baiya SARS-CoV-2 Vax 2 Vaccine for COVID-19 Disease

NCT05197712 ↗

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

EvaluationDrugModalityDoseRoute
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.