tetano
Editor, Senior Moderator
NPJ Vaccines
. 2020 Mar 13;5(1):22.
doi: 10.1038/s41541-020-0174-9.
Efficacy of FLU-v, a broad-spectrum influenza vaccine, in a randomized phase IIb human influenza challenge study
Olga Pleguezuelos[SUP] 1 [/SUP], Emma James[SUP] 1 [/SUP], Ana Fernandez[SUP] 1 [/SUP], Victor Lopes[SUP] 2 [/SUP], Luz Angela Rosas[SUP] 3 [/SUP], Adriana Cervantes-Medina[SUP] 4 [/SUP], Jason Cleath[SUP] 4 [/SUP], Kristina Edwards[SUP] 4 [/SUP], Dana Neitzey[SUP] 4 [/SUP], Wenjuan Gu[SUP] 5 [/SUP], Sally Hunsberger[SUP] 5 [/SUP], Jeffery K Taubenberger[SUP] 3 [/SUP], Gregory Stoloff[SUP] 1 [/SUP], Matthew J Memoli[SUP] 6 [/SUP]
Affiliations
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.
. 2020 Mar 13;5(1):22.
doi: 10.1038/s41541-020-0174-9.
Efficacy of FLU-v, a broad-spectrum influenza vaccine, in a randomized phase IIb human influenza challenge study
Olga Pleguezuelos[SUP] 1 [/SUP], Emma James[SUP] 1 [/SUP], Ana Fernandez[SUP] 1 [/SUP], Victor Lopes[SUP] 2 [/SUP], Luz Angela Rosas[SUP] 3 [/SUP], Adriana Cervantes-Medina[SUP] 4 [/SUP], Jason Cleath[SUP] 4 [/SUP], Kristina Edwards[SUP] 4 [/SUP], Dana Neitzey[SUP] 4 [/SUP], Wenjuan Gu[SUP] 5 [/SUP], Sally Hunsberger[SUP] 5 [/SUP], Jeffery K Taubenberger[SUP] 3 [/SUP], Gregory Stoloff[SUP] 1 [/SUP], Matthew J Memoli[SUP] 6 [/SUP]
Affiliations
- PMID: 33580054
- DOI: 10.1038/s41541-020-0174-9
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.