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B (yamagata lineage)-like virus antigen is a component of an adjuvanted quadrivalent subunit inactivated cell-derived influenza vaccine (aQIVc HD). The full registry name is A/(H3N2)-LIKE VIRUS ANTIGEN, B (YAMAGATA LINEAGE)-LIKE VIRUS ANTIGEN, B (VICTORIA LINEAGE)-LIKE VIRUS ANTIGEN, A/H1N1 INFLUENZA VACCINE, and the product is supplied by Seqirus UK Limited.[1] The B/Yamagata lineage is one of two lineages of influenza B viruses that circulate in humans; the other is the B/Victoria lineage.[5] The substance is an investigational vaccine component with no marketing authorisation in the product records.[1] The World Health Organization (WHO) maintains candidate vaccine viruses for the B/Yamagata lineage, including B/Phuket/3073/2013, to support vaccine development and production.[2]
The vaccine containing B (yamagata lineage)-like virus antigen is a subunit inactivated vaccine. It presents haemagglutinin surface proteins from four influenza strains — two influenza A strains (H1N1 and H3N2) and two influenza B lineages (Yamagata and Victoria) — to the immune system. The haemagglutination inhibition (HI) assay measures antibodies that block the haemagglutinin protein from binding to red blood cells, which serves as a marker of immune response.[1] The vaccine is adjuvanted, meaning it contains a substance that enhances the immune response. The B/Yamagata lineage has been a component of seasonal influenza vaccines recommended by WHO for both northern and southern hemisphere seasons.[5] Candidate vaccine viruses such as B/Phuket/3073/2013 and B/Brisbane/9/2014 have been developed and distributed by WHO collaborating centres for use in vaccine production.[2]
The vaccine containing this antigen is studied for the prevention of influenza infection. The clinical trial enrolled healthy individuals or individuals with stable comorbidities which increase their risk of complications from influenza infection.[1] In the broader context, influenza B viruses of the Yamagata lineage have circulated seasonally and have been associated with influenza illness across multiple seasons.[4] The European Centre for Disease Prevention and Control (ECDC) has reported low levels of B/Yamagata-lineage virus detections in recent seasons.[3]
B (yamagata lineage)-like virus antigen is given as part of a suspension for injection. The pharmaceutical form is a suspension for injection, and the route of administration is injection.[1] In the Phase 3 study, the adjuvanted quadrivalent subunit inactivated cell-derived influenza vaccine was administered as a 1.0 ml injection, while the individual strain components were listed as 0.5 ml injections.[1] The vaccine is a fixed combination product containing antigens from four influenza strains in one product record.[1]
One Phase 3 trial, the Celljuvant study (2023-503763-42-00), has been completed. It enrolled 6,300 participants aged 50 years and older, including healthy individuals and those with stable comorbidities that increase the risk of influenza complications.[1] The study had two sequential objectives. First, it assessed the clinical lot-to-lot consistency of three consecutive lots of the aQIVc HD vaccine in terms of immunogenicity for each vaccine strain. Second, it evaluated the immunological noninferiority of aQIVc HD compared with QIVr (a quadrivalent recombinant influenza vaccine) and aQIV (an adjuvanted quadrivalent influenza vaccine) for each vaccine strain.[1]
The primary outcomes were measured using the haemagglutination inhibition (HI) assay with cell-derived target viruses for the four vaccine strains. The measures included the Day 29 ratio of Geometric Mean Titer (GMTr) for lot-to-lot consistency, and Day 29 geometric mean titers (GMTs), GMTr, and seroconversion rates (SCRs) from Day 1 to Day 29 for the noninferiority comparisons.[1]
The supplementary sources provided do not report specific side effects for this vaccine. The clinical trial record lists safety as part of the study title but does not provide detailed adverse event data in the available summary.[1]
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