Immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1, NIBRG-14) vaccine administered by intramuscular or subcutaneous injection.
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.
Ikeno
Daisuke
D
The Chemo-Sero-Therapeutic Research Institute, Kikuchi Research Center, Kawabe Kyokushi, Kikuchi, Kumamoto 869-1298, Japan. ikeno-da@kaketsuken.or.jp
Kimachi
Kazuhiko
K
Kino
Yoichiro
Y
Harada
Seiichi
S
Yoshida
Kayo
K
Tochihara
Shinji
S
Itamura
Shigeyuki
S
Odagiri
Takato
T
Tashiro
Masato
M
Okada
Kenji
K
Miyazaki
Chiaki
C
Ueda
Kohji
K
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
D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines