A rapid immune response to 2009 influenza A(H1N1) vaccines in adults: a randomized, double-blind, controlled trial.
A double-blind, randomized, controlled trial involving 706 adults was conducted to evaluate the immunogenicity and safety of different dosages of whole-virion or split-virion H1N1 influenza vaccines with or without aluminum adjuvant. A rapid and strong immune response was induced at day 14 after the first injection. The seroprotection rates ranged from 72.7% (95% confidence interval [CI], 62.7%-81.1%) for 5-microg whole-virion aluminum formulation to 97.0% (95% CI, 90.9%-99.7%) for 30-microg split-virion nonaluminum formulation. All formulations were well tolerated. The incidences of mild, moderate, and severe reactions were 71 (10.1%), 15 (2.1%), and 1 (0.1%) of 706 reactions, respectively. The 15-microg split-virion formulation had the best immunogenicity and safety.
Wu
Jiang
J
Beijing Centers for Disease Control and Prevention, Beijing, China.
Li
Wei
W
Wang
Hua-Qing
HQ
Chen
Jiang-Ting
JT
Lv
Min
M
Zhou
Ji-Chen
JC
Liang
Xiao-Feng
XF
Fang
Han-Hua
HH
Liu
Yan
Y
Liu
Li-Ying
LY
Wang
Xu
X
Zhang
Wu-Li
WL
Zhang
Xiao-Mei
XM
Song
Li-Fei
LF
Qiu
Yuan-Zheng
YZ
Li
Chang-Gui
CG
Wang
Jun-Zhi
JZ
Wang
Yu
Y
Yin
Wei-Dong
WD
D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000536:Aluminum Hydroxide / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D000914:Antibodies, Viral / Q000097:blood*; D004311:Double-Blind Method; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D016015:Logistic Models; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome; D014771:Virion / Q000276:immunology; D055815:Young Adult
D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines; D000536:Aluminum Hydroxide