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

作者：Paul Spearman, Hong Jin, Peng Xiao, Kristeene A. Knopp, Henry Radziewicz, Marinka C. Tellier, Sasha E. Larsen, Bryan J. Berube, Xiao Song, J. G. Kidd, Karnail Singh, Li Zhuo, María Cristina Gingerich, Samuel Wu, Susan P. John, Angela R Branche, Ann R. Falsey, Rhea N. Coler, François Villinger, Biao He · 发表于：Science Advances · 年份：2025 · DOI：10.1126/sciadv.adw0896 · 被引用次数：11 · 研究领域：SARS-CoV-2 and COVID-19 Research、Respiratory viral infections research、Bacterial Infections and Vaccines

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.