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Clinical Trial Summary

The investigational product Baiya SARS-CoV-2 Vax 2 vaccine is a second-generation of protein subunit vaccine from plant to prevent COVID-19 disease. This is a Phase 2, randomised, and double-blinded study to assess the safety, tolerability, reactogenicity and immunogenicity of Baiya SARS-CoV-2 Vax 2 vaccine, when used as a booster vaccination following vaccination with the alternate and widely used COVID-19 vaccines.


Clinical Trial Description

This is a Phase 2, randomised, and double-blinded study. The participants will be randomised to receive either the investigational product or the placebo at a ratio of 2:1. 0.5 mL of the assigned vaccine will be administered as an IM injection. Each participant will be followed up for 6 months after vaccination. The primary objective aims to assess the safety, tolerability, and reactogenicity of Baiya SARS-CoV-2 Vax 2 vaccine in adults (18-64 years old) as a booster vaccination following vaccination with the alternate and widely used COVID-19 vaccines. The secondary objective aims to evaluate safety, tolerability, reactogenicity, and immunogenicity up to 28 days after the booster vaccination. An interim analysis of all safety and available immunogenicity data up to Visit 6 (Day 29 ±3) will be conducted for the DSMB review. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05873374
Study type Interventional
Source Baiya Phytopharm Co., Ltd.
Contact Peepattra Wantanasiri, Ph.D.
Phone 662-115-9860
Email peepattra.w@baiyaphytopharm.com
Status Not yet recruiting
Phase Phase 2
Start date December 2023
Completion date August 2024

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