New Generation mRNA Booster Vaccine Against Emerging VOCs

Summary

Primary：Objectives ：SafetyTo describe the safetyprofile of all participants in each group up to 6months post-dose.Immunogenicity：To demonstrate the superiorityof neutralizing antibodyresponse in terms of geometric mean titers (GMT) of mRNA vaccine compare with inactive vaccine28 days post dose. Secondary:Immunogenicity 1. To describe binding antibodyprofile at D01,D08, D15, D29,D91 and D181 of eachstudy group. 2. To describe the neutralizing antibody profile atD08,D15,D91 and D181of 600 participants for each studyintervention group. Exploratory:Cell-mediated immunity To describe the cellular immuneresponse profile at D01, D08, D15and D29, in a subset of 30 participants for each study group. Efficacy:To describe the occurrence of virologically-confirmed COVID-19 like illness and serologically confirmed SARS-CoV-2 infection.

Timeline

Start

2022-10

Primary completion

2023-05-11

Completion

2023-05-11

Publications

• Fang Y, Li JX, Duangdany D, Li Y, Guo XL, Phamisith C, Yu B, Shen MY, Luo B, Wang YZ, Liu SJ, Zhao FF, Xu CC, Qiu XH, Yan R, Gui YZ, Pei RJ, Wang J, Shen H, Guan WX, Li HW, Mayxay M. Safety, immunogenicity, and efficacy of a modified COVID-19 mRNA vaccine, SW-BIC-213, in healthy people aged 18 years and above: a phase 3 double-blinded, randomized, parallel controlled clinical trial in Lao PDR (Laos). EClinicalMedicine. 2023 Dec 13;67:102372. doi: 10.1016/j.eclinm.2023.102372. eCollection 2024 Jan.

Drugs

Indications

No indication recorded.