title: Immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1, NIBRG-14) vaccine administered by intramuscular or subcutaneous injection.
abstract: The immunogenicity and safety profile of an inactivated whole-virion influenza A (H5N1, NIBRG-14) vaccine with alum adjuvant that was administered by IM or SC injection in a phase I clinical study involving 120 healthy Japanese men aged 20-40 years is described. The serological response of the IM group was stronger than that of the SC group. Local adverse events were less severe with IM injection than with SC injection, while similar systemic adverse events were seen in both groups. These results indicate that, when administering an inactivated whole virion vaccine with alum adjuvant for pandemic influenza, IM injection may achieve better immunogenicity and safety than SC injection.
authors.affiliation: The Chemo-Sero-Therapeutic Research Institute, Kikuchi Research Center, Kawabe Kyokushi, Kikuchi, Kumamoto 869-1298, Japan. ikeno-da@kaketsuken.or.jp
authors.forename: Daisuke
authors.initials: D
authors.lastname: Ikeno
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Kimachi
authors.forename: Yoichiro
authors.initials: Y
authors.lastname: Kino
authors.forename: Seiichi
authors.initials: S
authors.lastname: Harada
authors.forename: Kayo
authors.initials: K
authors.lastname: Yoshida
authors.forename: Shinji
authors.initials: S
authors.lastname: Tochihara
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Itamura
authors.forename: Takato
authors.initials: T
authors.lastname: Odagiri
authors.forename: Masato
authors.initials: M
authors.lastname: Tashiro
authors.forename: Kenji
authors.initials: K
authors.lastname: Okada
authors.forename: Chiaki
authors.initials: C
authors.lastname: Miyazaki
authors.forename: Kohji
authors.initials: K
authors.lastname: Ueda
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D005260:Female; D006801:Humans; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D007251:Influenza, Human / Q000276:immunology* / Q000517:prevention & control / Q000821:virology; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D008297:Male; D014771:Virion / Q000276:immunology*; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines