1. A randomized, double‐blind, placebo‐controlled phase 1 and phase 2 clinical trial to evaluate efficacy and safety of a SARS‐CoV‐2 vaccine SCoK in adults
- Author
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Deyan Luo, Hongxing Pan, Peng He, Xiaolan Yang, Tao Li, Nianzhi Ning, Xin Fang, Wenjing Yu, Mingwei Wei, Hui Gao, Xin Wang, Hongjing Gu, Maodong Mei, Xinwang Li, Liangyan Zhang, Deyu Li, Chunrun Gao, Jinbang Gao, Guoqiang Fei, Ying Li, Yuguo Yang, Yi Xu, Wenjin Wei, Yansong Sun, Fengcai Zhu, Zhongyu Hu, and Hui Wang
- Subjects
clinical trial ,safety ,SARS‐CoV‐2 ,vaccine SCoK ,Medicine (General) ,R5-920 - Abstract
Abstract Background To determine an appropriate dose of, and immunization schedule for, a vaccine SCoK against COVID‐19 for an efficacy study; herein, we conducted randomized controlled trials to assess the immunogenicity and safety of this vaccine in adults. Methods These randomized, double‐blind, placebo‐controlled phase 1 and 2 trials of vaccine SCoK were conducted in Binhai District, Yan City, Jiangsu Province, China. Younger and older adult participants in phase 1 and 2 trials were sequentially recruited into different groups to be intramuscularly administered 20 or 40 μg vaccine SCoK or placebo. Participants were enrolled into our phase 1 and 2 studies to receive vaccine or placebo. Results No serious vaccine‐related adverse events were observed in either trial. In both trials, local and systemic adverse reactions were absent or mild in most participants. In our phase 1 and 2 studies, the vaccine induced significantly increased neutralizing antibody responses to pseudovirus and live SARS‐CoV‐2. The vaccine induced significant neutralizing antibody responses to live SARS‐CoV‐2 on day 14 after the last immunization, with NT50s of 80.45 and 92.46 in participants receiving 20 and 40 μg doses, respectively; the seroconversion rates were 95.83% and 100%. The vaccine SCoK showed a similar safety and immunogenicity profiles in both younger participants and older participants. The vaccine showed better immunogenicity in phase 2 than in phase 1 clinical trial. Additionally, the incidence of adverse reactions decreased significantly in phase 2 clinical trial. The vaccine SCoK was well tolerated and immunogenic.
- Published
- 2022
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