tetano
Editor, Senior Moderator
Open Forum Infect Dis. 2016 Jan 29;3(1)
fw015. doi: 10.1093/ofid/ofw015. eCollection 2016.
[h=1]Phase 1 Safety and Immunogenicity Study of a Quadrivalent Seasonal Flu Vaccine Comprising Recombinant Hemagglutinin-Flagellin Fusion Proteins.[/h] Tussey L[SUP]1[/SUP], Strout C[SUP]2[/SUP], Davis M[SUP]3[/SUP], Johnson C[SUP]4[/SUP], Lucksinger G[SUP]5[/SUP], Umlauf S[SUP]1[/SUP], Song L[SUP]1[/SUP], Liu G[SUP]1[/SUP], Abraham K[SUP]6[/SUP], White CJ[SUP]7[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] Background. We evaluated the safety and immunogenicity of VAX2012Q, a quadrivalent influenza vaccine comprising 4 hemagglutinin subunits fused to flagellin. Methods. In this dose-ranging, open-label study, healthy adults (18-40 years) were divided into 7 cohorts for evaluation of 5 dose levels and 3 component ratios. Dose levels were as follows: (1) 1 mcg per component of VAX128C (H1N1), VAX181 (H3N2), VAX173 (B-YAM), and VAX172 (B-VIC), respectively; (2) 2 mcg per component, respectively; (3) 2, 4, 4, and 4 mcg of each component, respectively; (4) 2, 4, 6, and 6 mcg of each component, respectively; and (5) 3 mcg per component, respectively. Tolerability and immunogenicity data were analyzed. Results. Three hundred sixteen subjects received VAX2012Q (309 per protocol). At all dose levels, 54% to 65% of subjects reported mild injection site pain, the most common local reaction. Moderate injection site pain increased at dose levels 2 through 5 (22%-42%, compared with 20% at dose level 1). Systemic symptoms were mostly mild to moderate with moderate symptoms increasing in dose levels 3 and 4. Three dose level 3 subjects (6%) reported severe, transient chills and or fever. Mean fold rises in hemagglutination inhibition titers ranged from 2.5 to 6.9 despite high baseline titers. Mean seroprotection rates were ≥90% and mean seroconversion rates were ≥40% for all strains in all groups postvaccination. Conclusions. VAX2012Q elicited immune responses at all dose levels with no significant safety concerns. Doses of 2 or 3 mcg per component provided a favorable balance of tolerability and immunogenicity.
[h=4]KEYWORDS:[/h] flagellin adjuvant; influenza vaccine; recombinant vaccine; seasonal influenza; vaccine
PMID: 26925433 [PubMed]
fw015. doi: 10.1093/ofid/ofw015. eCollection 2016.[h=1]Phase 1 Safety and Immunogenicity Study of a Quadrivalent Seasonal Flu Vaccine Comprising Recombinant Hemagglutinin-Flagellin Fusion Proteins.[/h] Tussey L[SUP]1[/SUP], Strout C[SUP]2[/SUP], Davis M[SUP]3[/SUP], Johnson C[SUP]4[/SUP], Lucksinger G[SUP]5[/SUP], Umlauf S[SUP]1[/SUP], Song L[SUP]1[/SUP], Liu G[SUP]1[/SUP], Abraham K[SUP]6[/SUP], White CJ[SUP]7[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] Background. We evaluated the safety and immunogenicity of VAX2012Q, a quadrivalent influenza vaccine comprising 4 hemagglutinin subunits fused to flagellin. Methods. In this dose-ranging, open-label study, healthy adults (18-40 years) were divided into 7 cohorts for evaluation of 5 dose levels and 3 component ratios. Dose levels were as follows: (1) 1 mcg per component of VAX128C (H1N1), VAX181 (H3N2), VAX173 (B-YAM), and VAX172 (B-VIC), respectively; (2) 2 mcg per component, respectively; (3) 2, 4, 4, and 4 mcg of each component, respectively; (4) 2, 4, 6, and 6 mcg of each component, respectively; and (5) 3 mcg per component, respectively. Tolerability and immunogenicity data were analyzed. Results. Three hundred sixteen subjects received VAX2012Q (309 per protocol). At all dose levels, 54% to 65% of subjects reported mild injection site pain, the most common local reaction. Moderate injection site pain increased at dose levels 2 through 5 (22%-42%, compared with 20% at dose level 1). Systemic symptoms were mostly mild to moderate with moderate symptoms increasing in dose levels 3 and 4. Three dose level 3 subjects (6%) reported severe, transient chills and or fever. Mean fold rises in hemagglutination inhibition titers ranged from 2.5 to 6.9 despite high baseline titers. Mean seroprotection rates were ≥90% and mean seroconversion rates were ≥40% for all strains in all groups postvaccination. Conclusions. VAX2012Q elicited immune responses at all dose levels with no significant safety concerns. Doses of 2 or 3 mcg per component provided a favorable balance of tolerability and immunogenicity.
[h=4]KEYWORDS:[/h] flagellin adjuvant; influenza vaccine; recombinant vaccine; seasonal influenza; vaccine
PMID: 26925433 [PubMed]