Brandon Essink1, Carlos Fierro2, Jeffrey Rosen3, Amparo L Figueroa4, Bin Zhang5, Carole Verhoeven6, Jonathan Edelman7, Igor Smolenov8. 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.
Abstract
OBJECTIVE: 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. METHODS: 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. RESULTS: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. CONCLUSION: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).
RCT Entities:
OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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).
Authors: Giovanna Elisa Calabrò; Sara Boccalini; Donatella Panatto; Caterina Rizzo; Maria Luisa Di Pietro; Fasika Molla Abreha; Marco Ajelli; Daniela Amicizia; Angela Bechini; Irene Giacchetta; Piero Luigi Lai; Stefano Merler; Chiara Primieri; Filippo Trentini; Sara Violi; Paolo Bonanni; Chiara de Waure Journal: Int J Environ Res Public Health Date: 2022-03-31 Impact factor: 3.390
Authors: Michele A Kohli; Michael Maschio; Joaquin F Mould-Quevedo; Michael Drummond; Milton C Weinstein Journal: Hum Vaccin Immunother Date: 2021-09-22 Impact factor: 3.452
Authors: Mikhail P Kostinov; Elena A Latysheva; Aristitsa M Kostinova; Nelly K Akhmatova; Tatyana V Latysheva; Anna E Vlasenko; Yulia A Dagil; Ekaterina A Khromova; Valentina B Polichshuk Journal: Vaccines (Basel) Date: 2020-11-02