Randomized, Double-Blind Controlled Phase 3 Trial Comparing the Immunogenicity of High-Dose and Standard-Dose Influenza Vaccine in Adults 65 Years of Age and Older

被引:294
|
作者
Falsey, Ann R. [1 ,2 ]
Treanor, John J. [2 ]
Tornieporth, Nadia [3 ]
Capellan, Jose [6 ]
Gorse, Geoffrey J. [4 ,5 ]
机构
[1] Rochester Gen Hosp, Infect Dis Unit, Dept Med, Rochester, NY 14621 USA
[2] Univ Rochester, Sch Med, Rochester, NY USA
[3] Sanofi Pasteur, Swiftwater, PA USA
[4] St Louis Univ, St Louis, MO 63103 USA
[5] Vet Affairs Med Ctr, St Louis Dept, St Louis, MO USA
[6] Sanofi Pasteur, Toronto, ON, Canada
来源
JOURNAL OF INFECTIOUS DISEASES | 2009年 / 200卷 / 02期
关键词
VIRUS-VACCINES; ANTIBODY-RESPONSE; EFFICACY; MORTALITY; IMMUNITY; SAFETY; LIVE;
D O I
10.1086/599790
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Background. Influenza-associated morbidity and mortality has not decreased in the last decade, despite increased receipt of vaccine. To improve the immunogenicity of influenza vaccine, a high-dose (HD) trivalent, inactivated influenza vaccine was developed. Methods. A multicenter, randomized, double-blind controlled study was conducted to compare HD vaccine (which contains 60 mu g of hemagglutinin per strain) with the licensed standard-dose (SD) vaccine (which contains 15 mu g of hemagglutinin per strain) in adults >= 65 years of age. Results. HD vaccine was administered to 2575 subjects, and SD vaccine was administered to 1262 subjects. There was a statistically significant increase in the rates of seroconversion and mean hemagglutination inhibition titers at day 28 after vaccination among those who received HD vaccine, compared with those who received SD vaccine. Mean postvaccination titers for individuals who received HD vaccine were 116 for H1N1, 609 for H3N2, and 69 for B strain; for those who received SD vaccine, mean postvaccination titers were as 67 for H1N1, 333 for H3N2, and 52 for B strain. The HD vaccine met superiority criteria for both A strains, and the responses for B strain met noninferiority criteria. Seroprotection rates were also higher for those who received HD vaccine than for those who received SD vaccine vaccine, for all strains. Local reactions were more frequent in individuals who received HD vaccine, but the reactions were mild to moderate. Conclusions. There was a statistically significant increase in the level of antibody response induced by HD influenza vaccine, compared with that induced by SD vaccine, without an attendant increase in the rate or severity of clinically relevant adverse reactions. These results suggest that the high-dose vaccine may provide improved protective benefits for older adults.
引用
收藏
页码:172 / 180
页数:9
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