Immunogenicity and Safety of Comvigen (Bivalent) Vaccine

Summary

This study will assess the safety, reactogenicity and immunogenicity of a single dose of Comvigen (Bivalent, ChulaCov19 BNA159.2) vaccine or BIVALENT Pfizer/BNT vaccine as a booster among healthy males and non-pregnant females aged 18-64 years after receiving a previous booster dose of any approved mRNA COVID-19 vaccine for more than 3 months. The results of Combiven will be compared to BIVALENT Pfizer/BNT vaccine.

Timeline

Start

2023-10-09

Primary completion

2024-02

Completion

2024-02

Publications

• Jantarabenjakul W, Nantanee R, Puthanakit T, Gatechompol S, Avihingsanon A, Punrin S, Tantawichien T, Nitayaphan S, Thitithanyanont A, Buranapraditkun S, Jongkaewwattana A, Ketloy C, Prompetchara E, Lawpoolsri S, Wijagkanalan W, Alameh MG, Hong L, Samija M, Weissman D, Ruxrungtham K; ChulaVac006 Study Team. Immunogenicity and safety of 'Comvigen', a bivalent SARS-CoV-2 vaccine, in comparison to Comirnaty bivalent vaccine in Thailand: a phase 2, non-inferiority randomised trial. Lancet Reg Health Southeast Asia. 2025 Aug 15;40:100650. doi: 10.1016/j.lansea.2025.100650. eCollection 2025 Sep.

Drugs

Indications

No indication recorded.