Immunogenic Properties and Safety of a Quadrivalent Inactivated Subunit Adjuvanted Influenza Vaccine in Adults Aged 18 to 85 Years at the End of the COVID-19 Pandemic in the 2022–2023 Season

<b>Background</b>: SARS-CoV-2 infection has raised concerns about altered immune responses, creating a need to evaluate influenza vaccine performance in the post-COVID period. This study aimed to compare the immunogenicity and safety of a quadrivalent inactivated subunit adjuvanted influenza vaccine in adults aged 18-85 years during the 2022-2023 season. <b>Methods</b>: A total of 144 adults were enrolled: group 1, aged 18-59 years (<i>n</i> = 124), and group 2, aged 60-85 years (<i>n</i> = 20). All received a quadrivalent inactivated subunit adjuvanted vaccine containing 5 μg of each influenza antigen and 500 μg of Azoximer bromide. IgG antibodies to vaccine strains were measured at baseline and days 30-32 using the hemagglutination inhibition assay. Participants were actively monitored for adverse events by telephone. <b>Results</b>: The Geometric Mean Fold Increase (GMFI) met the efficacy criteria in both age groups (≥2.5 for 18-59 years and ≥2.0 for 60-85 years), with no significant differences. The seroprotection rate reached accepted thresholds for most strains but was below criteria for B/Victoria in the 18-59 group (48%) and for B/Phuket in the 60-85 group (35%). Significant between-group differences were observed for B/Victoria (<i>p</i> = 0.01) and B/Phuket (<i>p</i> = 0.007). Seroconversion met criteria for all strains in younger adults, but for older adults, it was insufficient for B/Phuket (20%, below the ≥30% threshold; <i>p</i> = 0.05 vs. 18-59 years). Local reactions occurred in 24.2% and systemic in 11.3% of younger adults; in older adults, in 20% and 15%, respectively. All resolved spontaneously within 1-3 days. <b>Conclusions</b>: The quadrivalent adjuvanted influenza vaccine demonstrated acceptable immunogenicity and safety in adults aged 18-85 years despite potential post-COVID immune alterations.

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Journal
Vaccines
Published
2026-02-14
DOI
https://doi.org/10.3390/vaccines14020181
Primary Topic
Influenza Virus Research Studies
Type
article
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article

Immunogenic Properties and Safety of a Quadrivalent Inactivated Subunit Adjuvanted Influenza Vaccine in Adults Aged 18 to 85 Years at the End of the COVID-19 Pandemic in the 2022–2023 Season

В. Б. Полищук, А. Е. Власенко, M. P. Kostinov, M.A. Kvasova et al.
Vaccines
Influenza Virus Research Studies
article

Immunogenic Properties and Safety of a Quadrivalent Inactivated Subunit Adjuvanted Influenza Vaccine in Adults Aged 18 to 85 Years at the End of the COVID-19 Pandemic in the 2022–2023 Season

В. Б. Полищук, А. Е. Власенко, M. P. Kostinov, M.A. Kvasova, А. М. Костинова, А. А. Камелева, А. M. Kostinov, Irina V. Mekhantseva, E. V. Prutskova, Yvette Albahansa Mana, Anna A. Khamidulina, Anastasia Kachnova, Sofia Iushkova, Irina Solovеva, Lilia Gladkova, Yulia Dagil, Natalia Andreeva
article en

Abstract

<b>Background</b>: SARS-CoV-2 infection has raised concerns about altered immune responses, creating a need to evaluate influenza vaccine performance in the post-COVID period. This study aimed to compare the immunogenicity and safety of a quadrivalent inactivated subunit adjuvanted influenza vaccine in adults aged 18-85 years during the 2022-2023 season. <b>Methods</b>: A total of 144 adults were enrolled: group 1, aged 18-59 years (<i>n</i> = 124), and group 2, aged 60-85 years (<i>n</i> = 20). All received a quadrivalent inactivated subunit adjuvanted vaccine containing 5 μg of each influenza antigen and 500 μg of Azoximer bromide. IgG antibodies to vaccine strains were measured at baseline and days 30-32 using the hemagglutination inhibition assay. Participants were actively monitored for adverse events by telephone. <b>Results</b>: The Geometric Mean Fold Increase (GMFI) met the efficacy criteria in both age groups (≥2.5 for 18-59 years and ≥2.0 for 60-85 years), with no significant differences. The seroprotection rate reached accepted thresholds for most strains but was below criteria for B/Victoria in the 18-59 group (48%) and for B/Phuket in the 60-85 group (35%). Significant between-group differences were observed for B/Victoria (<i>p</i> = 0.01) and B/Phuket (<i>p</i> = 0.007). Seroconversion met criteria for all strains in younger adults, but for older adults, it was insufficient for B/Phuket (20%, below the ≥30% threshold; <i>p</i> = 0.05 vs. 18-59 years). Local reactions occurred in 24.2% and systemic in 11.3% of younger adults; in older adults, in 20% and 15%, respectively. All resolved spontaneously within 1-3 days. <b>Conclusions</b>: The quadrivalent adjuvanted influenza vaccine demonstrated acceptable immunogenicity and safety in adults aged 18-85 years despite potential post-COVID immune alterations.

VaccinesVol. 14(2)
Privolzhsky Research Medical University (RU), Peoples' Friendship University of Russia (RU), Sechenov University (RU), Chuvash State University (RU), Ulyanovsk State University (RU), Moscow City Hospital No 29 (RU), Karaganda Medical University (KZ), Samara State Medical University (RU), Research Institute of Vaccines and Sera. Mechnikov of the Russian Academy of Medical Sciences (RU), City Clinical Hospital (RU), Federal Medical-Biological Agency (RU)
I.M. Sechenov First Moscow State Medical University
Good health and well-being
Openalex Percentile: Top 54%
Influenza Virus Research Studies
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