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B (Victoria lineage)-like virus antigen is a component of an investigational adjuvanted quadrivalent subunit inactivated cell-derived influenza vaccine. The full registry name groups it with antigens from the A/H3N2-like virus, B (Yamagata lineage)-like virus, and A/H1N1 influenza vaccine strains, reflecting the four-strain composition of the vaccine.[1] The product appears in CTIS records under the name "adjuvanted Quadrivalent Subunit Inactivated Cell-derived Influenza Vaccine" and is developed by Seqirus UK Limited.[1] It is an investigational substance with no marketing authorisation in the product records.[1]
The B/Victoria lineage is one of two influenza B lineages that circulate in humans, the other being B/Yamagata. Candidate vaccine viruses antigenically like B/Washington/02/2019 have been prepared and certified for use in cell culture-based vaccine production for the 2020–2021 northern hemisphere influenza season.[2] The World Health Organization coordinates the selection and distribution of such candidate viruses through its Global Influenza Surveillance and Response System.[2]
Influenza vaccines work by presenting viral surface proteins, principally haemagglutinin, to the immune system so that antibodies are produced against them. The B (Victoria lineage)-like virus antigen is one of four haemagglutinin antigens in the quadrivalent vaccine, each selected to match circulating influenza strains.[1] Antibodies against haemagglutinin block the virus from attaching to and entering host cells, which is the basis of the haemagglutination inhibition (HI) assay used to measure vaccine responses in the Celljuvant study.[1]
There is evidence that immunity to one influenza B lineage can provide some cross-reactive protection against the other lineage, a phenomenon relevant to the choice of including both B lineages in quadrivalent vaccines.[3] Viral interference between the two B lineages has also been described, suggesting that exposure to one lineage may influence responses to the other.[3]
The therapeutic area recorded in the registry is virus diseases, consistent with the use of influenza vaccines to prevent illness caused by influenza viruses.[1]
The pharmaceutical form recorded in the product records is a suspension for injection, and the route of administration is injection.[1] In the Celljuvant study, the high-dose adjuvanted quadrivalent vaccine was given as a 1.0 millilitre injection, while the individual antigen components, including the B (Victoria lineage)-like virus antigen, were listed at 0.5 millilitres per injection in the intervention descriptions.[1]
One completed Phase 3 trial, the Celljuvant study, investigated this substance as part of the high-dose adjuvanted quadrivalent cell-derived influenza vaccine.[1] The trial 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 clinical lot-to-lot consistency of three consecutive lots of the high-dose vaccine in terms of immunogenicity for each vaccine strain, measured by haemagglutination inhibition assay using cell-derived target viruses at Day 29.[1] Second, it evaluated immunological noninferiority of the high-dose vaccine compared with two other influenza vaccines, a quadrivalent recombinant vaccine and an adjuvanted quadrivalent vaccine, for each vaccine strain.[1]
The primary outcome measures included the Day 29 ratio of geometric mean titers (GMTr) for the three lots compared in pairs, and the Day 29 geometric mean titers, GMTr, seroconversion rates, and seroconversion rate differences for the high-dose vaccine versus the two comparator vaccines, all measured by haemagglutination inhibition assay using cell-derived target viruses for the four vaccine strains.[1]
The trial is recorded as completed, meaning that the planned study activities have finished. Results are not summarised in the registry record provided here.[1] The substance appears as the test product in one trial, and in one product record it is part of a fixed combination.[1]
The registry record for this trial does not report side effect data, and the supplementary sources provided do not describe adverse events for this specific vaccine. Therefore, no side effect information can be stated for this substance based on the available sources.
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