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)

作者：Yi Fang, Jingxin Li, Davone Duangdany, Li Yang, Xi-Lin Guo, Chanthala Phamisith, Bo Yu, Mingyun Shen, Bin Luo, Yuzhu Wang, Sijun Liu, Fanfan Zhao, Congcong Xu, Xu-Hui Qiu, Rong Yan, Yuzhou Gui, Rongjuan Pei, Jie Wang, Haifa Shen, Wuxiang Guan, Hang-Wen Li, Mayfong Mayxay · 发表于：EClinicalMedicine · 年份：2023 · DOI：10.1016/j.eclinm.2023.102372 · 被引用次数：18 · 研究领域：SARS-CoV-2 and COVID-19 Research、RNA Interference and Gene Delivery、vaccines and immunoinformatics approaches

Background: The mRNA vaccine has demonstrated significant effectiveness in protecting against SARS-CoV-2 during the pandemic, including against severe forms of the disease caused by emerging variants. In this study, we examined safety, immunogenicity, and relative efficacy of a heterologous booster of the lipopolyplex (LPP)-based mRNA vaccine (SW-BIC-213) versus a homologous booster of an inactivated vaccine (BBIBP) in Laos. Methods: In this phase 3 clinical trial, which was randomized, parallel controlled and double-blinded, healthy adults aged 18 years and above were recruited from the Southern Savannakhet Provincial Hospital and Champhone District Hospital. The primary outcomes were safety and immunogenicity, with efficacy as an exploratory endpoint. Participants who were fully immunized with a two-dose inactivated vaccine for more than 6 months were assigned equally to either the SW-BIC-213 group (25 μg) or BBIBP group. The primary safety endpoint was to describe the safety profile of all participants in each group up to 6 months post-booster immunization. The primary immunogenic outcome was to demonstrate the superiority of the neutralizing antibody response, in terms of geometric mean titers (GMTs) of SW-BIC-213, compared with BBIBP 28 days after the booster dose. The exploratory efficacy endpoint aimed to assess the relative efficacy of SW-BIC-213 compared to BBIBP against virologically confirmed symptomatic COVID-19 over a 6-month period. The trial was registered with...