tetano
Editor, Senior Moderator
NPJ Vaccines. 2020 Mar 13;5:22. doi: 10.1038/s41541-020-0174-9. eCollection 2020.
Efficacy of FLU-v, a broad-spectrum influenza vaccine, in a randomized phase IIb human influenza challenge study.
Pleguezuelos O[SUP]1[/SUP], James E[SUP]1[/SUP], Fernandez A[SUP]1[/SUP], Lopes V[SUP]2[/SUP], Rosas LA[SUP]3[/SUP], Cervantes-Medina A[SUP]4[/SUP], Cleath J[SUP]4[/SUP], Edwards K[SUP]4[/SUP], Neitzey D[SUP]4[/SUP], Gu W[SUP]5[/SUP], Hunsberger S[SUP]5[/SUP], Taubenberger JK[SUP]3[/SUP], Stoloff G[SUP]1[/SUP], Memoli MJ[SUP]4[/SUP].
Author information
Abstract
FLU-v, developed by PepTcell (SEEK), is a peptide vaccine aiming to provide a broadly protective cellular immune response against influenza A and B. A randomized, double-blind, placebo-controlled, single-center, phase IIb efficacy and safety trial was conducted. One hundred and fifty-three healthy individuals 18-55 years of age were randomized to receive one or two doses of adjuvanted FLU-v or adjuvanted placebo subcutaneously on days -43 and -22, prior to intranasal challenge on day 0 with the A/California/04/2009/H1N1 human influenza A challenge virus. The primary objective of the study was to identify a reduction in mild to moderate influenza disease (MMID) defined as the presence of viral shedding and clinical influenza symptoms. Single-dose adjuvanted FLU-v recipients (n = 40) were significantly less likely to develop MMID after challenge vs placebo (n = 42) (32.5% vs 54.8% p = 0.035). FLU-v should continue to be evaluated and cellular immunity explored further as a possible important correlate of protection against influenza.
? This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply 2020.
KEYWORDS:
Randomized controlled trials; Translational research
PMID:32194999PMCID:PMC7069936DOI:10.1038/s41541-020-0174-9
Free PMC Article
Efficacy of FLU-v, a broad-spectrum influenza vaccine, in a randomized phase IIb human influenza challenge study.
Pleguezuelos O[SUP]1[/SUP], James E[SUP]1[/SUP], Fernandez A[SUP]1[/SUP], Lopes V[SUP]2[/SUP], Rosas LA[SUP]3[/SUP], Cervantes-Medina A[SUP]4[/SUP], Cleath J[SUP]4[/SUP], Edwards K[SUP]4[/SUP], Neitzey D[SUP]4[/SUP], Gu W[SUP]5[/SUP], Hunsberger S[SUP]5[/SUP], Taubenberger JK[SUP]3[/SUP], Stoloff G[SUP]1[/SUP], Memoli MJ[SUP]4[/SUP].
Author information
Abstract
FLU-v, developed by PepTcell (SEEK), is a peptide vaccine aiming to provide a broadly protective cellular immune response against influenza A and B. A randomized, double-blind, placebo-controlled, single-center, phase IIb efficacy and safety trial was conducted. One hundred and fifty-three healthy individuals 18-55 years of age were randomized to receive one or two doses of adjuvanted FLU-v or adjuvanted placebo subcutaneously on days -43 and -22, prior to intranasal challenge on day 0 with the A/California/04/2009/H1N1 human influenza A challenge virus. The primary objective of the study was to identify a reduction in mild to moderate influenza disease (MMID) defined as the presence of viral shedding and clinical influenza symptoms. Single-dose adjuvanted FLU-v recipients (n = 40) were significantly less likely to develop MMID after challenge vs placebo (n = 42) (32.5% vs 54.8% p = 0.035). FLU-v should continue to be evaluated and cellular immunity explored further as a possible important correlate of protection against influenza.
? This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply 2020.
KEYWORDS:
Randomized controlled trials; Translational research
PMID:32194999PMCID:PMC7069936DOI:10.1038/s41541-020-0174-9
Free PMC Article