Human monoclonal antibody F61 nasal spray effectively protected high-risk populations from SARS-CoV-2 variants during the COVID-19 pandemic from late 2022 to early 2023 in China.

IF 8.4 2区 医学 Q1 IMMUNOLOGY
Emerging Microbes & Infections Pub Date : 2024-12-01 Epub Date: 2024-03-26 DOI:10.1080/22221751.2023.2284297
Ying Liu, Jiayou Zhang, Wen Liu, Yongbing Pan, Shunan Ruan, Xuanxuan Nian, Wei Chen, Lina Sun, Qiangling Yin, Xin Yue, Qingliang Li, Fang Gui, Cong Wu, Shuzhen Wang, Yunkai Yang, Zhaofei Jing, Feiguang Long, Zejun Wang, Zeyu Zhang, Chaolin Huang, Kai Duan, Mifang Liang, Xiaoming Yang
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引用次数: 0

Abstract

Following the national dynamic zero-COVID strategy adjustment, the utilization of broad-spectrum nasal neutralizing antibodies may offer an alternative approach to controlling the outbreak of Omicron variants between late 2022 and early 2023 in China. This study involved an investigator-initiated trial (IIT) to assess the pharmacokinetic, safety and efficacy of the F61 nasal spray. A total of 2,008 participants were randomly assigned to receive F61 nasal spray (24 mg/0.8 mL/dose) or normal saline (0.8 mL/dose) and 1336 completed the follow-up in the IIT. Minimal absorption of F61 antibody into the bloodstream was detected in individuals receiving F61 nasal spray for seven consecutive days. No treatment-emergent adverse reactions of grade 3 severity or higher were reported. In the one-dose cohort, the 7-day cumulative SARS-CoV-2 infection rate was 79.0% in the F61 group and 82.6% in the placebo group, whereas, in the multiple-dose (once daily for 7 consecutive days) cohort, the rates were 6.55% in the F61 group and 23.83% in the placebo group. The laboratory-confirmed efficacy of F61 was 3.78% (-3.74%-10.75%) in the one-dose cohort and 72.19% (57.33%-81.87%) in the multiple-dose cohort. In the real-world study, 60,225 volunteers in four different regions were administered the F61 nasal spray based on the subject's wishes, over 90% efficacy rate was observed against different Omicron variants. The F61 nasal spray, with its favourable safety profile, could be a promising prophylactic monoclonal antibody against SARS-CoV-2 VOCs.

人单克隆抗体F61鼻喷雾剂在2022年底至2023年初中国COVID-19大流行期间有效保护高危人群免受SARS-CoV-2变体的感染。
随着国家动态零冠战略调整,利用广谱鼻中和抗体可能是2022年底至2023年初中国控制欧米克隆变异爆发的另一种方法。本研究包括一项研究者发起的试验(IIT),以评估F61鼻喷雾剂的药代动力学、安全性和有效性。共有2008名参与者被随机分配接受F61鼻喷雾剂(24 mg/0.8 mL/剂量)或生理盐水(0.8 mL/剂量),1336名参与者在IIT中完成了随访。在连续7天接受F61鼻喷雾剂的个体中检测到F61抗体进入血液的最小吸收。治疗后出现的3级或以上严重不良反应未见报道。在单剂量组中,F61组的7天累积SARS-CoV-2感染率为79.0%,安慰剂组为82.6%,而在多剂量组(每天1次,连续7天)中,F61组的7天累积感染率为6.55%,安慰剂组为23.83%。F61在单剂量组的实验室确认有效率为3.78%(-3.74% ~ 10.75%),在多剂量组的实验室确认有效率为72.19%(57.33% ~ 81.87%)。在现实世界的研究中,根据受试者的意愿,在四个不同地区的60,225名志愿者中使用了F61鼻喷雾剂,对不同的Omicron变体观察到90%以上的有效率。F61鼻喷雾剂具有良好的安全性,可能是一种有前景的抗SARS-CoV-2 VOCs的预防性单克隆抗体。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Emerging Microbes & Infections
Emerging Microbes & Infections IMMUNOLOGY-MICROBIOLOGY
CiteScore
26.20
自引率
2.30%
发文量
276
审稿时长
20 weeks
期刊介绍: Emerging Microbes & Infections is a peer-reviewed, open-access journal dedicated to publishing research at the intersection of emerging immunology and microbiology viruses. The journal's mission is to share information on microbes and infections, particularly those gaining significance in both biological and clinical realms due to increased pathogenic frequency. Emerging Microbes & Infections is committed to bridging the scientific gap between developed and developing countries. This journal addresses topics of critical biological and clinical importance, including but not limited to: - Epidemic surveillance - Clinical manifestations - Diagnosis and management - Cellular and molecular pathogenesis - Innate and acquired immune responses between emerging microbes and their hosts - Drug discovery - Vaccine development research Emerging Microbes & Infections invites submissions of original research articles, review articles, letters, and commentaries, fostering a platform for the dissemination of impactful research in the field.
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