title: A rapid immune response to 2009 influenza A(H1N1) vaccines in adults: a randomized, double-blind, controlled trial.
abstract: 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.
authors.affiliation: Beijing Centers for Disease Control and Prevention, Beijing, China.
authors.forename: Jiang
authors.initials: J
authors.lastname: Wu
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.forename: Hua-Qing
authors.initials: HQ
authors.lastname: Wang
authors.forename: Jiang-Ting
authors.initials: JT
authors.lastname: Chen
authors.forename: Min
authors.initials: M
authors.lastname: Lv
authors.forename: Ji-Chen
authors.initials: JC
authors.lastname: Zhou
authors.forename: Xiao-Feng
authors.initials: XF
authors.lastname: Liang
authors.forename: Han-Hua
authors.initials: HH
authors.lastname: Fang
authors.forename: Yan
authors.initials: Y
authors.lastname: Liu
authors.forename: Li-Ying
authors.initials: LY
authors.lastname: Liu
authors.forename: Xu
authors.initials: X
authors.lastname: Wang
authors.forename: Wu-Li
authors.initials: WL
authors.lastname: Zhang
authors.forename: Xiao-Mei
authors.initials: XM
authors.lastname: Zhang
authors.forename: Li-Fei
authors.initials: LF
authors.lastname: Song
authors.forename: Yuan-Zheng
authors.initials: YZ
authors.lastname: Qiu
authors.forename: Chang-Gui
authors.initials: CG
authors.lastname: Li
authors.forename: Jun-Zhi
authors.initials: JZ
authors.lastname: Wang
authors.forename: Yu
authors.initials: Y
authors.lastname: Wang
authors.forename: Wei-Dong
authors.initials: WD
authors.lastname: Yin
mesh_terms: 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
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines; D000536:Aluminum Hydroxide