Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trialResearch in context
Yu-Zhou Gui,
Xue-Ning Li,
Jing-Xin Li,
Ming-Yun Shen,
Mei-Wei Zhang,
Ye Cao,
Hong-Rong Xu,
Hui Li,
Jie Cheng,
Liang Pan,
Ying-Lei Yi,
Li-Yu Liang,
Cheng-Yin Yu,
Gang-Yi Liu,
Chen Yu,
Bi-Jie Hu,
Feng-Cai Zhu,
Fei Liang,
Haifa Shen,
Jing-Ying Jia,
Hang-Wen Li,
Jian Zhou,
Jia Fan
Affiliations
Yu-Zhou Gui
Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China
Xue-Ning Li
Zhongshan Hospital, Fudan University, Shanghai, China
Jing-Xin Li
Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China
Ming-Yun Shen
StemiRNA Therapeutics Co., Ltd., Shanghai, China
Mei-Wei Zhang
Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China
Ye Cao
Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China
Hong-Rong Xu
Zhongshan Hospital, Fudan University, Shanghai, China
Hui Li
Zhongshan Hospital, Fudan University, Shanghai, China
Jie Cheng
Zhongshan Hospital, Fudan University, Shanghai, China
Liang Pan
Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China
Ying-Lei Yi
StemiRNA Therapeutics Co., Ltd., Shanghai, China
Li-Yu Liang
Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China
Cheng-Yin Yu
Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China
Gang-Yi Liu
Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China
Chen Yu
Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China
Bi-Jie Hu
Zhongshan Hospital, Fudan University, Shanghai, China
Feng-Cai Zhu
Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China
Fei Liang
Zhongshan Hospital, Fudan University, Shanghai, China
Haifa Shen
StemiRNA Therapeutics Co., Ltd., Shanghai, China
Jing-Ying Jia
Shanghai Xuhui Central Hospital/Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research & Quality Consistency Evaluation for Drugs, Shanghai, China
Hang-Wen Li
StemiRNA Therapeutics Co., Ltd., Shanghai, China
Jian Zhou
Zhongshan Hospital, Fudan University, Shanghai, China
Summary: Background: We assessed the safety and immunogenicity of a core–shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults. Methods: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25μg (n = 20), or SW-BIC-213-45μg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355). Findings: Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 μg, n = 20, or 45 μg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 μg and 45 μg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45μg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group. Interpretation: SW-BIC-213, a core–shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults. Funding: Shanghai Municipal Government, the Science and Technology and Economic Commission of Shanghai Pudong New Area, and mRNA Innovation and Translation Center of Shanghai.
