tetano
Editor, Senior Moderator
Vaccine. 2019 Oct 18. pii: S0264-410X(19)31384-2. doi: 10.1016/j.vaccine.2019.10.021. [Epub ahead of print] [h=1]Immunogenicity and safety of MF59-adjuvanted quadrivalent influenza vaccine versus standard and alternate B strain MF59-adjuvanted trivalent influenza vaccines in older adults.[/h]
Essink B[SUP]1[/SUP], Fierro C[SUP]2[/SUP], Rosen J[SUP]3[/SUP], Figueroa AL[SUP]4[/SUP], Zhang B[SUP]5[/SUP], Verhoeven C[SUP]6[/SUP], Edelman J[SUP]7[/SUP], Smolenov I[SUP]8[/SUP].
[h=3]Author information[/h] 1 Meridian Clinical Research, Creighton, NE, USA. Electronic address: bessink@mcrmed.com. 2 Johnson County Clin Trials, Lenexa, KS, USA. Electronic address: cfierro@jcct.com. 3 Alliance of MultiSpeciality Research, Coral Gables, FL, USA. Electronic address: Jeffrey.Rosen@amrllc.com. 4 Clinical Vaccines, Seqirus Inc., Cambridge, MA, USA. Electronic address: amparo.figueroa@seqirus.com. 5 Clinical Vaccines, Seqirus Inc., Cambridge, MA, USA. Electronic address: bin.zhang@seqirus.com. 6 Seqirus Netherlands BV, Amsterdam, the Netherlands. Electronic address: Carole.Verhoeven@Seqirus.com. 7 Clinical Vaccines, Seqirus Inc., Cambridge, MA, USA. Electronic address: Jonathan.edelman@seqirus.com. 8 Clinical Vaccines, Seqirus Inc., Cambridge, MA, USA. Electronic address: Igor.Smolenov@Seqirus.com.
[h=3]Abstract[/h] [h=4]OBJECTIVE:[/h] Evaluate whether adjuvanted quadrivalent influenza vaccine (aQIV) elicits a noninferior immune response compared with a licensed adjuvanted trivalent influenza vaccine (aTIV-1; Fluad™) and aTIV-2 containing an alternate B strain, examine whether aQIV had immunological superiority for the B strain absent from aTIV comparators, and evaluate reactogenicity and safety among adults ≥65 years.
[h=4]METHODS:[/h] In a multicenter, double-blind, randomized controlled trial, adults ≥65 years were randomized 2:1:1 to vaccination with aQIV (n = 889), aTIV-1 (n = 445), or aTIV-2 (n = 444) during the 2017-2018 influenza season. Immunogenicity was assessed by hemagglutination inhibition (HI) assay conducted on serum samples collected before vaccination and 21 days after vaccination for homologous influenza strains.
[h=4]RESULTS:[/h] aQIV met non-inferiority criteria for geometric mean titer ratios (GMT ratios) and seroconversion rate (SCR) differences against aTIV. The upper bounds of the 2-sided 95% confidence interval (CI) for GMT ratios were <1.5 for all 4 strains (A/H1N1 = 1.27, A/H3N2 = 1.09, B-Yamagata = 1.08, B-Victoria = 1.08). The upper bounds of the 95% CI of the SCR differences were <10% for all 4 strains (A/H1N1 = 7.76%, A/H3N2 = 4.96%, B-Yamagata = 3.27%, B-Victoria = 2.55%). aQIV also met superiority criteria (upper bound of 95% CI for GMT ratios <1 and SCR differences <0) for B strain absent from aTIV comparators (B-Yamagata GMT ratio = 0.70, SCR difference = -8.81%; B-Victoria GMT ratio = 0.78, SCR difference = -8.11%). aQIV and aTIV vaccines were immunogenic and well-tolerated. The immunological benefit of aQIV was also demonstrated in age subgroups 65-74 years, 75-84 years, and ≥85 years and in those with high comorbidity risk scores. Reactogenicity profiles were generally comparable.
[h=4]CONCLUSION:[/h] aQIV induces a similar immune response as the licensed aTIV vaccine against homologous influenza strains and has a comparable reactogenicity and safety profile. Superior immunogenicity against the additional B strain was observed, indicating that aQIV could provide a broader protection than aTIV against influenza in older adults (NCT03314662).
Copyright ? 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.
[h=4]KEYWORDS:[/h] Adjuvanted quadrivalent influenza vaccine; Adjuvanted trivalent influenza vaccine; Elderly; Fluad; Influenza vaccine; MF59
PMID: 31635976 DOI: 10.1016/j.vaccine.2019.10.021
Essink B[SUP]1[/SUP], Fierro C[SUP]2[/SUP], Rosen J[SUP]3[/SUP], Figueroa AL[SUP]4[/SUP], Zhang B[SUP]5[/SUP], Verhoeven C[SUP]6[/SUP], Edelman J[SUP]7[/SUP], Smolenov I[SUP]8[/SUP].
[h=3]Author information[/h] 1 Meridian Clinical Research, Creighton, NE, USA. Electronic address: bessink@mcrmed.com. 2 Johnson County Clin Trials, Lenexa, KS, USA. Electronic address: cfierro@jcct.com. 3 Alliance of MultiSpeciality Research, Coral Gables, FL, USA. Electronic address: Jeffrey.Rosen@amrllc.com. 4 Clinical Vaccines, Seqirus Inc., Cambridge, MA, USA. Electronic address: amparo.figueroa@seqirus.com. 5 Clinical Vaccines, Seqirus Inc., Cambridge, MA, USA. Electronic address: bin.zhang@seqirus.com. 6 Seqirus Netherlands BV, Amsterdam, the Netherlands. Electronic address: Carole.Verhoeven@Seqirus.com. 7 Clinical Vaccines, Seqirus Inc., Cambridge, MA, USA. Electronic address: Jonathan.edelman@seqirus.com. 8 Clinical Vaccines, Seqirus Inc., Cambridge, MA, USA. Electronic address: Igor.Smolenov@Seqirus.com.
[h=3]Abstract[/h] [h=4]OBJECTIVE:[/h] Evaluate whether adjuvanted quadrivalent influenza vaccine (aQIV) elicits a noninferior immune response compared with a licensed adjuvanted trivalent influenza vaccine (aTIV-1; Fluad™) and aTIV-2 containing an alternate B strain, examine whether aQIV had immunological superiority for the B strain absent from aTIV comparators, and evaluate reactogenicity and safety among adults ≥65 years.
[h=4]METHODS:[/h] In a multicenter, double-blind, randomized controlled trial, adults ≥65 years were randomized 2:1:1 to vaccination with aQIV (n = 889), aTIV-1 (n = 445), or aTIV-2 (n = 444) during the 2017-2018 influenza season. Immunogenicity was assessed by hemagglutination inhibition (HI) assay conducted on serum samples collected before vaccination and 21 days after vaccination for homologous influenza strains.
[h=4]RESULTS:[/h] aQIV met non-inferiority criteria for geometric mean titer ratios (GMT ratios) and seroconversion rate (SCR) differences against aTIV. The upper bounds of the 2-sided 95% confidence interval (CI) for GMT ratios were <1.5 for all 4 strains (A/H1N1 = 1.27, A/H3N2 = 1.09, B-Yamagata = 1.08, B-Victoria = 1.08). The upper bounds of the 95% CI of the SCR differences were <10% for all 4 strains (A/H1N1 = 7.76%, A/H3N2 = 4.96%, B-Yamagata = 3.27%, B-Victoria = 2.55%). aQIV also met superiority criteria (upper bound of 95% CI for GMT ratios <1 and SCR differences <0) for B strain absent from aTIV comparators (B-Yamagata GMT ratio = 0.70, SCR difference = -8.81%; B-Victoria GMT ratio = 0.78, SCR difference = -8.11%). aQIV and aTIV vaccines were immunogenic and well-tolerated. The immunological benefit of aQIV was also demonstrated in age subgroups 65-74 years, 75-84 years, and ≥85 years and in those with high comorbidity risk scores. Reactogenicity profiles were generally comparable.
[h=4]CONCLUSION:[/h] aQIV induces a similar immune response as the licensed aTIV vaccine against homologous influenza strains and has a comparable reactogenicity and safety profile. Superior immunogenicity against the additional B strain was observed, indicating that aQIV could provide a broader protection than aTIV against influenza in older adults (NCT03314662).
Copyright ? 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.
[h=4]KEYWORDS:[/h] Adjuvanted quadrivalent influenza vaccine; Adjuvanted trivalent influenza vaccine; Elderly; Fluad; Influenza vaccine; MF59
PMID: 31635976 DOI: 10.1016/j.vaccine.2019.10.021