在一项开放标签的1期临床试验中，成人和青少年鼻内副流感病毒5型（PIV5）载体COVID-19疫苗的安全性和免疫原性

IF 12.5 1区综合性期刊 Q1 MULTIDISCIPLINARY SCIENCES

Science Advances Pub Date : 2025-07-04 DOI:10.1126/sciadv.adw0896

Paul Spearman, Hong Jin, Peng Xiao, Kristeene Knopp, Henry Radziewicz, Marinka Tellier, Sasha E. Larsen, Bryan J. Berube, Xiao Song, Jamie Kidd, Karnail Singh, Zhuo Li, Maria Cristina Gingerich, Samuel Wu, Susan P. John, Angela Branche, Ann R. Falsey, Rhea Coler, Francois J. Villinger, Biao He

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引用次数: 0

摘要

尽管已有fda批准的COVID-19疫苗，但COVID-19仍在造成大量死亡。需要一种有效的COVID-19疫苗，既能提供持久的免疫力，又能将反应性降到最低。cvvxga1是一种基于piv5的鼻内COVID-19疫苗，表达SARS-CoV-2的Spike (S)蛋白，在成人和青少年的1期研究中进行了评估。cvvxga1耐受性良好，无严重不良事件（ae）或发热报告。征求的局部和系统性ae大多是温和的。CVXGA1在所有组中均引起s特异性血清和粘膜抗体以及CD8+细胞毒性T淋巴细胞反应。在SARS-CoV-2 δ波和欧微米波期间，与低剂量cvvxga1 （LD）组相比，接受高剂量cvvxga1 （HD）组的症状性COVID-19感染率显着降低。数据表明，CVXGA1是一种潜在有效的鼻内COVID-19疫苗，具有最小的反应原性和免疫原性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Safety and immunogenicity of intranasal parainfluenza virus type 5 (PIV5)–vectored COVID-19 vaccine in adults and teens in an open-label phase 1 trial

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Safety and immunogenicity of intranasal parainfluenza virus type 5 (PIV5)–vectored COVID-19 vaccine in adults and teens in an open-label phase 1 trial

COVID-19 continues causing substantial mortality despite existing FDA-approved COVID-19 vaccines. An effective COVID-19 vaccine providing durable immunity with minimal reactogenicity is needed. CVXGA1, a PIV5-based intranasal COVID-19 vaccine expressing the Spike (S) protein of SARS-CoV-2, was evaluated in this phase 1 study in adults and teens. CVXGA1 was well tolerated without serious adverse events (AEs) or fever reported. Solicited local and systemic AEs were mostly mild. CVXGA1 elicited S-specific serum and mucosal antibodies and CD8⁺ cytotoxic T lymphocyte responses in all groups. Significantly lower rates of symptomatic COVID-19 infection were reported in groups receiving high-dose CVXGA1 (HD) compared to that in the group receiving low-dose CVXGA1 (LD) during the SARS-CoV-2 delta and omicron waves. The data indicate that CVXGA1 is a potentially effective intranasal COVID-19 vaccine that is immunogenic with minimal reactogenicity.

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来源期刊

Science Advances 综合性期刊-综合性期刊

CiteScore

21.40

自引率

1.50%

发文量

1937

审稿时长

29 weeks

期刊介绍： Science Advances, an open-access journal by AAAS, publishes impactful research in diverse scientific areas. It aims for fair, fast, and expert peer review, providing freely accessible research to readers. Led by distinguished scientists, the journal supports AAAS's mission by extending Science magazine's capacity to identify and promote significant advances. Evolving digital publishing technologies play a crucial role in advancing AAAS's global mission for science communication and benefitting humankind.