BACKGROUND: Two influenza B lineages have been co-circulating since the 1980s, and because inactivated trivalent influenza vaccine (TIV) contains only one B strain, it provides little/no protection against the alternate B-lineage. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in healthy adults. METHODS: Subjects received one dose of QIV (lot 1, 2, or 3) or one of two TIVs (B strain from Victoria or Yamagata lineage); randomization was 2:2:2:1:1. Hemagglutination-inhibition assays were performed 21-days post-vaccination; superiority of QIV versus TIV for the alternate B-lineage was demonstrated if the 95% confidence interval (CI) lower limit for the GMT ratio was ≥1.5, and non-inferiority against the shared strains was demonstrated if the 95% CI upper limit for the GMT ratio was ≤1.5. Reactogenicity and safety were assessed during the post-vaccination period. NCT01196975. RESULTS: Immunogenicity of QIV lots was consistent, QIV was superior to TIV for the alternate B-lineage strain, and QIV was non-inferior versus TIVs for shared strains (A/H1N1, A/H3N2, B-strain). Reactogenicity and safety profile of the QIV was consistent with seasonal influenza vaccines. CONCLUSION: QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains, and without compromising safety.
RCT Entities:
BACKGROUND: Two influenza B lineages have been co-circulating since the 1980s, and because inactivated trivalent influenza vaccine (TIV) contains only one B strain, it provides little/no protection against the alternate B-lineage. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in healthy adults. METHODS: Subjects received one dose of QIV (lot 1, 2, or 3) or one of two TIVs (B strain from Victoria or Yamagata lineage); randomization was 2:2:2:1:1. Hemagglutination-inhibition assays were performed 21-days post-vaccination; superiority of QIV versus TIV for the alternate B-lineage was demonstrated if the 95% confidence interval (CI) lower limit for the GMT ratio was ≥1.5, and non-inferiority against the shared strains was demonstrated if the 95% CI upper limit for the GMT ratio was ≤1.5. Reactogenicity and safety were assessed during the post-vaccination period. NCT01196975. RESULTS: Immunogenicity of QIV lots was consistent, QIV was superior to TIV for the alternate B-lineage strain, and QIV was non-inferior versus TIVs for shared strains (A/H1N1, A/H3N2, B-strain). Reactogenicity and safety profile of the QIV was consistent with seasonal influenza vaccines. CONCLUSION: QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains, and without compromising safety.
Authors: Carolien E van de Sandt; YingYing Dou; Stella E Vogelzang-van Trierum; Kim B Westgeest; Mark R Pronk; Albert D M E Osterhaus; Ron A M Fouchier; Guus F Rimmelzwaan; Marine L B Hillaire Journal: J Gen Virol Date: 2015-04-21 Impact factor: 3.891
Authors: Jiwon Lee; Daniel R Boutz; Veronika Chromikova; M Gordon Joyce; Christopher Vollmers; Kwanyee Leung; Andrew P Horton; Brandon J DeKosky; Chang-Han Lee; Jason J Lavinder; Ellen M Murrin; Constantine Chrysostomou; Kam Hon Hoi; Yaroslav Tsybovsky; Paul V Thomas; Aliaksandr Druz; Baoshan Zhang; Yi Zhang; Lingshu Wang; Wing-Pui Kong; Daechan Park; Lyubov I Popova; Cornelia L Dekker; Mark M Davis; Chalise E Carter; Ted M Ross; Andrew D Ellington; Patrick C Wilson; Edward M Marcotte; John R Mascola; Gregory C Ippolito; Florian Krammer; Stephen R Quake; Peter D Kwong; George Georgiou Journal: Nat Med Date: 2016-11-07 Impact factor: 53.440
Authors: Francesca Ferrara; Joanne Marie M Del Rosario; Kelly A S da Costa; Rebecca Kinsley; Simon Scott; Sasan Fereidouni; Craig Thompson; Paul Kellam; Sarah Gilbert; George Carnell; Nigel Temperton Journal: Front Immunol Date: 2021-05-24 Impact factor: 7.561