tetano
Editor, Senior Moderator
Clin Vaccine Immunol. 2015 May 20. pii: CVI.00098-15. [Epub ahead of print]
[h=1]A synthetic influenza vaccine induces a cellular immune response which correlates with reduction in symptomatology and virus shedding in a randomised Phase Ib live viral challenge in man.[/h] Pleguezuelos O[SUP]1[/SUP], Robinson S[SUP]1[/SUP], Fernandez A[SUP]1[/SUP], Stoloff GA[SUP]1[/SUP], Mann A[SUP]2[/SUP], Gilbert A[SUP]2[/SUP], Balaratnam G[SUP]2[/SUP], Wilkinson T[SUP]3[/SUP], Lambkin-Williams R[SUP]2[/SUP], Oxford J[SUP]4[/SUP], Caparr?s-Wanderley W[SUP]5[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Current influenza vaccines elicit primarily antibody-based immunity. They require yearly revaccination and cannot be manufactured until identification of the circulating viral strain(s). These issues remain to be addressed. Here we report a Phase Ib trial of a vaccine candidate (FLU-v) eliciting cellular immunity.
[h=4]METHODS:[/h] Thirty-two males seronegative by HAI to the challenge virus participated in this single-centre, randomised, double-blind study. Volunteers received one dose of either adjuvant alone (Placebo, n=16) or FLU-v (500ug) and adjuvant (n=16), both in saline. Twenty-one days later FLU-v (n=15) and Placebo (n=13) volunteers were challenged with influenza A/Wisconsin/67/2005 (H3N2) and monitored for seven days. Safety, tolerability and cellular responses were assessed pre- and post-vaccination. Virus shedding and clinical signs were assessed post-challenge.
[h=4]RESULTS:[/h] FLU-v was safe and well tolerated. No difference in the pre-vaccination FLU-v specific IFN-γ response was seen between groups (1.4?0.2 and 1.6?0.5 fold increase vs negative control, Average ? SEM, Placebo and FLU-v respectively). Nineteen days post-vaccination, the FLU-v group, but not the Placebo, developed FLU-v specific IFN-γ responses (8.2?3.9 vs 1.3?0.1, fold increase vs negative control ? SEM, FLU-v vs Placebo, p=0.0005). FLU-v specific cellular responses also correlated with reductions in both viral titre (p=0.01) and symptom score (p=0.02) post-challenge.
[h=4]CONCLUSION:[/h] Increased cellular immunity specific to FLU-v correlates with reductions in both symptom score and virus load. Trial registered under EUDRACT Identifier 2009-014716-35 and NCT01226758.
Copyright ? 2015, American Society for Microbiology. All Rights Reserved.
PMID: 25994549 [PubMed - as supplied by publisher]
[h=1]A synthetic influenza vaccine induces a cellular immune response which correlates with reduction in symptomatology and virus shedding in a randomised Phase Ib live viral challenge in man.[/h] Pleguezuelos O[SUP]1[/SUP], Robinson S[SUP]1[/SUP], Fernandez A[SUP]1[/SUP], Stoloff GA[SUP]1[/SUP], Mann A[SUP]2[/SUP], Gilbert A[SUP]2[/SUP], Balaratnam G[SUP]2[/SUP], Wilkinson T[SUP]3[/SUP], Lambkin-Williams R[SUP]2[/SUP], Oxford J[SUP]4[/SUP], Caparr?s-Wanderley W[SUP]5[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Current influenza vaccines elicit primarily antibody-based immunity. They require yearly revaccination and cannot be manufactured until identification of the circulating viral strain(s). These issues remain to be addressed. Here we report a Phase Ib trial of a vaccine candidate (FLU-v) eliciting cellular immunity.
[h=4]METHODS:[/h] Thirty-two males seronegative by HAI to the challenge virus participated in this single-centre, randomised, double-blind study. Volunteers received one dose of either adjuvant alone (Placebo, n=16) or FLU-v (500ug) and adjuvant (n=16), both in saline. Twenty-one days later FLU-v (n=15) and Placebo (n=13) volunteers were challenged with influenza A/Wisconsin/67/2005 (H3N2) and monitored for seven days. Safety, tolerability and cellular responses were assessed pre- and post-vaccination. Virus shedding and clinical signs were assessed post-challenge.
[h=4]RESULTS:[/h] FLU-v was safe and well tolerated. No difference in the pre-vaccination FLU-v specific IFN-γ response was seen between groups (1.4?0.2 and 1.6?0.5 fold increase vs negative control, Average ? SEM, Placebo and FLU-v respectively). Nineteen days post-vaccination, the FLU-v group, but not the Placebo, developed FLU-v specific IFN-γ responses (8.2?3.9 vs 1.3?0.1, fold increase vs negative control ? SEM, FLU-v vs Placebo, p=0.0005). FLU-v specific cellular responses also correlated with reductions in both viral titre (p=0.01) and symptom score (p=0.02) post-challenge.
[h=4]CONCLUSION:[/h] Increased cellular immunity specific to FLU-v correlates with reductions in both symptom score and virus load. Trial registered under EUDRACT Identifier 2009-014716-35 and NCT01226758.
Copyright ? 2015, American Society for Microbiology. All Rights Reserved.
PMID: 25994549 [PubMed - as supplied by publisher]