Collaborative study on the cross-reactivity of two influenza B viral components in single radial immunodiffusion assay using quadrivalent influenza vaccines in Japan from 2015/16 to 2021-22 influenza season.

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  • Additional Information
    • Source:
      Publisher: Academic Press Country of Publication: England NLM ID: 9004494 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1095-8320 (Electronic) Linking ISSN: 10451056 NLM ISO Abbreviation: Biologicals Subsets: MEDLINE
    • Publication Information:
      Original Publication: London ; San Diego : Academic Press, c1990-
    • Subject Terms:
      Influenza Vaccines*/immunology ; Influenza B virus*/immunology ; Cross Reactions*/immunology ; Immunodiffusion*/methods ; Influenza, Human*/immunology ; Influenza, Human*/prevention & control ; Influenza, Human*/virology; Japan ; Humans ; Seasons ; Hemagglutinin Glycoproteins, Influenza Virus/immunology ; Antigens, Viral/immunology
    • Abstract:
      A quadrivalent influenza vaccine (QIV) has been available in Japan since the 2015/2016 influenza season. Single radial immunodiffusion (SRID) assays are currently used worldwide to measure the hemagglutinin (HA) content of influenza vaccine components because they are simple, accurate, and the regulatory requirement, ensuring consistency in manufacture for the HA content. However, the cross-reactivity of antisera against the two lineages of the influenza B virus (IFVB) may cause inaccurate quantification of HA content in QIVs using the SRID assay. To examine cross-reactivity and develop an appropriate procedure for accurate measurement of vaccine potency, a collaborative study with four Japanese vaccine manufacturers was conducted to measure the HA contents of trivalent influenza vaccines (TIVs) and QIVs by SRID assay with a single and a mixture of reference antigens (refAgs) from each lineage of IFVB for seven influenza seasons from 2015/16 to 2021/22. The cross-reactivity of the two IFVB components in the SRID assay varied depending on the vaccine viruses. Our study demonstrated that it is useful to validate a suitable combination for each refAg and reference antiserum by selecting the combination showing similar HA contents between experimental TIV and QIV before lot release testing.
      Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
      (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
    • Contributed Indexing:
      Keywords: Cross-reactivity; Hemagglutinin content; Influenza B virus component; Mixed reference antigen; Quadrivalent influenza vaccine; Single radial immunodiffusion assay
    • Accession Number:
      0 (Influenza Vaccines)
      0 (Hemagglutinin Glycoproteins, Influenza Virus)
      0 (Antigens, Viral)
    • Publication Date:
      Date Created: 20241031 Date Completed: 20241121 Latest Revision: 20241121
    • Publication Date:
      20241122
    • Accession Number:
      10.1016/j.biologicals.2024.101797
    • Accession Number:
      39481190