Safety and immunogenicity of a subvirion inactivated influenza A/H5N1 vaccine with or without aluminum hydroxide among healthy elderly adults.

Publication Type
Journal Article
Year of Publication
Brady, Rebecca C; Treanor, John J; Atmar, Robert L; Keitel, Wendy A; Edelman, Robert; Chen, Wilbur H; Winokur, Patricia; Belshe, Robert; Graham, Irene L; Noah, Diana Lee; Guo, Kuo; Hill, Heather
Date Published
2009 Aug 13
Adjuvants, Immunologic; Aged; Aluminum Hydroxide; Antibodies, Viral; Dose-Response Relationship, Drug; Female; Hemagglutination Inhibition Tests; Hemagglutinin Glycoproteins, Influenza Virus; Humans; Influenza A Virus, H5N1 Subtype; Influenza Vaccines; Influenza, Human; Male; Neutralization Tests; Vaccination

A total of 600 healthy adults > or =65 years were randomized to receive 2 vaccinations 1 month apart of a subvirion avian influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45microg of hemagglutinin (HA) with or without aluminum hydroxide (AlOH). All formulations were safe. Groups given the vaccine with AlOH had more injection site discomfort. Dose-related increases in antibody responses were noted after the second vaccination. Antibody responses to the vaccine were not enhanced by AlOH at any HA dose level. A microneutralization titer > or =40 was observed in 36% and 40% of subjects who received 45microg of HA with or without AlOH, respectively.