Efficacy, immunogenicity, and safety of heterologous boosting with a novel chimera Chinese mRNA (RQ3013) SARS-CoV-2 vaccine: A randomized, double-blind, active-controlled trial.

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Tác giả: Gao-Xiang Chen, Jing-Jing Chen, De-Fang Dai, Jun Dai, Hui-Lan Fan, Wei-Min Gao, Jian-Chang He, Li-Li Huang, Tao Huang, Zhi-Wei Jiang, Wei Li, Xiao-Zhong Li, Jin-Zhong Lin, Xiao-Qiang Liu, Jing Lu, Yang-Yang Qi, Lorenz von Seidlein, Feng Shi, Hong Su, Si-Wen Tao, Xuan-Yi Wang, Yan-Xia Wang, Zhong-Fang Wang, Xue-Mei Yan, Xiao-Yun Yang, Xiu-Liang Yang, Lin Yuan, Zhi-Fei Zhan, Qiong-Na Zhang, Zhi-Hua Zhang, Ming-Xuan Zhao, Jiang-Bing Zheng, Yan-Xiang Zou

Ngôn ngữ: eng

Ký hiệu phân loại: 496.3616 Niger-Congo languages

Thông tin xuất bản: United States : Human vaccines & immunotherapeutics , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 746088

 A randomized, double-blind, controlled phase 3 trial was conducted during a COVID-19 outbreak after the initial, stringent zero-Covid policy was relaxed in three provinces. Eligible adults aged ≥18 years who had received three doses of inactivated COVID-19 vaccines 6 months earlier were randomly assigned in a 1:1 ratio to receive either one intramuscular injection of RQ3013 or ZF2002 vaccine. The primary end point was protection against PCR-confirmed symptomatic SARS-CoV-2 infection with onset at least 7 days after the booster. A total of 3,167 and 3,169 eligible participants received one dose of RQ3013 or ZF2002 vaccine, respectively. COVID-19 illness was confirmed in 91 participants in the ZF2002 group (11.8 per 100 person years
  95% confidence interval [CI]: 9.6-14.6) and in 45 participants in the RQ3013 group (5.7 per 100 person-years
  95% CI: 4.3-7.7) during a 4-month follow-up, resulting in a relative efficacy of 51.7% (95% CI, 30.9-66.2%) (
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