tetano
Editor, Senior Moderator
Sci Adv
. 2025 Jul 4;11(27):eadw0896.
doi: 10.1126/sciadv.adw0896. Epub 2025 Jul 4. 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
Paul Spearman[SUP] 1 [/SUP], Hong Jin[SUP] 2 [/SUP], Peng Xiao[SUP] 3 [/SUP], Kristeene Knopp[SUP] 2 [/SUP], Henry Radziewicz[SUP] 2 [/SUP], Marinka Tellier[SUP] 2 [/SUP], Sasha E Larsen[SUP] 4 [/SUP], Bryan J Berube[SUP] 4 [/SUP], Xiao Song[SUP] 5 [/SUP], Jamie Kidd[SUP] 1 [/SUP], Karnail Singh[SUP] 1 [/SUP], Zhuo Li[SUP] 2 [/SUP], Maria Cristina Gingerich[SUP] 2 [/SUP], Samuel Wu[SUP] 2 [/SUP], Susan P John[SUP] 3 [/SUP], Angela Branche[SUP] 6 [/SUP], Ann R Falsey[SUP] 6 [/SUP], Rhea Coler[SUP] 4 7 [/SUP], Francois J Villinger[SUP] 3 [/SUP], Biao He[SUP] 2 [/SUP]
Affiliations
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[SUP]+[/SUP] 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.
. 2025 Jul 4;11(27):eadw0896.
doi: 10.1126/sciadv.adw0896. Epub 2025 Jul 4. 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
Paul Spearman[SUP] 1 [/SUP], Hong Jin[SUP] 2 [/SUP], Peng Xiao[SUP] 3 [/SUP], Kristeene Knopp[SUP] 2 [/SUP], Henry Radziewicz[SUP] 2 [/SUP], Marinka Tellier[SUP] 2 [/SUP], Sasha E Larsen[SUP] 4 [/SUP], Bryan J Berube[SUP] 4 [/SUP], Xiao Song[SUP] 5 [/SUP], Jamie Kidd[SUP] 1 [/SUP], Karnail Singh[SUP] 1 [/SUP], Zhuo Li[SUP] 2 [/SUP], Maria Cristina Gingerich[SUP] 2 [/SUP], Samuel Wu[SUP] 2 [/SUP], Susan P John[SUP] 3 [/SUP], Angela Branche[SUP] 6 [/SUP], Ann R Falsey[SUP] 6 [/SUP], Rhea Coler[SUP] 4 7 [/SUP], Francois J Villinger[SUP] 3 [/SUP], Biao He[SUP] 2 [/SUP]
Affiliations
- PMID: 40614182
- PMCID: PMC12227042
- DOI: 10.1126/sciadv.adw0896
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[SUP]+[/SUP] 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.