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Статья
An inactivated, adjuvanted whole virion clade 2.2 H5N1 (A/Chicken/Astana/6/ 05) influenza vaccine is safe and immunogenic in a single dose in humans
2021
In this study, we assessed in humans the immunogenicity and safety of one dose (7.5 or 15 μg of hemagglutinin [HA]) of a whole-virion inactivated prepandemic influenza vaccine adjuvanted with aluminum hydroxide. The vaccine strain was made by reverse genetics from the highly pathogenic avian A/Chicken/Astana/6/05 (H5N1) clade 2.2 strain isolated from a dead bird in Kazakhstan. The humoral immune response was evaluated after a single vaccination by hemagglutination inhibition (HI) and microneutralization (MN) assays. The vaccine was safe and immunogenic, inducing seroconversion in 55% of the evaluated patients, with a geometric mean titer (GMT) of 17.1 and a geometric mean increase (GMI) of 3.42 after a dose of 7.5 μg in the HI test against the vaccine strain. The rate of seroconversion increased up to 70% when the dose of 15 μg was used. The percentages of individuals achieving anti-HA titers of ≥1:40 were 52.5% and 57.5% for the 7.5- and 15-μg dose groups, respectively. Similar results were obtained when antibodies were analyzed in anMNtest. Substantial cross-neutralization titers (seroconversion in 35% and 52.5% of subjects in the two dose groups, respectively) were detected against heterologous clade 1 strain NIBRG14 (H5N1). Thus, one dose of this whole-virion prepandemic vaccine adjuvanted with aluminum has the potential to be effective against H5N1 viruses of different clades. Copyright © 2013, American Society for Microbiology.
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Версии
- 1. Version of Record от 2021-04-27
Метаданные
Название журнала
- Clinical and Vaccine Immunology
Том
- 20
Выпуск
- 8
Страницы
- 1314-1319
Ключевые слова
- aluminum hydroxide; immunological adjuvant; inactivated vaccine; influenza vaccine; Influenza virus hemagglutinin; neutralizing antibody; virus antibody; adult; animal cell; antibody titer; article; cladistics; cross reaction; death; drug dose comparison; drug induced headache; drug megadose; drug safety; female; human; humoral immunity; immunogenicity; Influenza virus A H5N1; injection site erythema; injection site induration; injection site pain; injection site reaction; injection site swelling; Kazakhstan; low drug dose; major clinical study; malaise; male; nonhuman; nucleotide sequence; pandemic influenza; priority journal; rhinitis; seroconversion; single drug dose; sore throat; viral genetics; virion; virus isolation; virus neutralization; virus strain; Adjuvants, Immunologic; Adult; Aluminum Hydroxide; Animals; Antibodies, Viral; Cross Reactions; Hemagglutination Inhibition Tests; Humans; Influenza A Virus, H5N1 Subtype; Influenza Vaccines; Influenza, Human; Kazakhstan; Male; Middle Aged; Neutralization Tests; Reverse Genetics; Russia; Vaccines, Inactivated; Young Adult
Тип документа
- journal article
Источник
- scopus
