Safety and immunogenicity of a subvirion inactivated influenza A/H5N1 vaccine with or without aluminum hydroxide among healthy elderly adults.
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.
Brady
Rebecca C
RC
Cincinnati Children's Hospital Medical Center, OH 45229-3039, United States. rebecca.brady@cchmc.org
Treanor
John J
JJ
Atmar
Robert L
RL
Keitel
Wendy A
WA
Edelman
Robert
R
Chen
Wilbur H
WH
Winokur
Patricia
P
Belshe
Robert
R
Graham
Irene L
IL
Noah
Diana Lee
DL
Guo
Kuo
K
Hill
Heather
H
D000276:Adjuvants, Immunologic; D000368:Aged; D000536:Aluminum Hydroxide / Q000276:immunology*; D000914:Antibodies, Viral / Q000097:blood; D004305:Dose-Response Relationship, Drug; D005260:Female; D006385:Hemagglutination Inhibition Tests; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000276:immunology; D006801:Humans; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D008297:Male; D009500:Neutralization Tests; D014611:Vaccination
D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D019267:Hemagglutinin Glycoproteins, Influenza Virus; D007252:Influenza Vaccines; D000536:Aluminum Hydroxide