作者
Shengli Xia, Kai Duan, Yuntao Zhang, Dongyang Zhao, Huajun Zhang, Zhiqiang Xie, Xinguo Li, Cheng Peng, Yanbo Zhang, Wei Zhang, Yunkai Yang, Wei Chen, Xiaoxiao Gao, Wangyang You, Xuewei Wang, Zejun Wang, Zhengli Shi, Yanxia Wang, Xuqin Yang, Lianghao Zhang, Lili Huang, Qian Wang, Jia Lu, Yongli Yang, Jing Guo, Wei Zhou, Xin Wan, Cong Wu, Wenhui Wang, Shihe Huang, Jianhui Du, Ziyan Meng, An Pan, Zhiming Yuan, Shuo Shen, Wanshen Guo, Xiaoming Yang
发表日期
2020/9/8
期刊
Jama
卷号
324
期号
10
页码范围
951-960
出版商
American Medical Association
简介
Importance
A vaccine against coronavirus disease 2019 (COVID-19) is urgently needed.
Objective
To evaluate the safety and immunogenicity of an investigational inactivated whole-virus COVID-19 vaccine in China.
Interventions
In the phase 1 trial, 96 participants were assigned to 1 of the 3 dose groups (2.5, 5, and 10 μg/dose) and an aluminum hydroxide (alum) adjuvant–only group (n = 24 in each group), and received 3 intramuscular injections at days 0, 28, and 56. In the phase 2 trial, 224 adults were randomized to 5 μg/dose in 2 schedule groups (injections on days 0 and 14 [n = 84] vs alum only [n = 28], and days 0 and 21 [n = 84] vs alum only [n = 28]).
Design, Setting, and Participants
Interim analysis of ongoing randomized, double-blind, placebo-controlled, phase 1 and 2 clinical trials to assess an inactivated COVID-19 vaccine. The trials were conducted in Henan Province, China, among 96 (phase …
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