title: Immunogenicity and safety of an AS03-adjuvanted H5N1 pandemic influenza vaccine in Korean adults: a phase IV, randomized, open-label, controlled study.
abstract: BACKGROUND
  AS03-adjuvanted H5N1 pandemic influenza vaccines have been assessed in an extensive clinical development program conducted in North America, Europe, and Asia including children from 6 months of age, adults, and elderly adults. We evaluated AS03-H5N1 in Korean adults 18 through 60 years of age.
  
  
  METHODS
  This Phase IV, randomized, study was conducted to assess the immunogenicity, reactogenicity, and safety of two doses (3.75μg of hemagglutinin antigen) of A/Indonesia/5/2005 (H5N1) adjuvanted with AS03 given 21 days apart in Korean adults. Antibody responses were assessed using hemagglutination-inhibition (HI) assays against the vaccine strain and a vaccine-heterologous strain (A/Vietnam/1194/2004) 21 days after the second dose. A control group (safety) received a licensed seasonal inactivated trivalent influenza vaccine (TIV). Reactogenicity was assessed for 7 days after each vaccination, and unsolicited adverse events were assessed for 182 days following vaccination in both study groups (NCT01730378).
  
  
  RESULTS
  AS03-H5N1 was immunogenic and elicited robust HI antibody responses with seroconversion rates of 100% for the vaccine strain and 69.1% for the heterologous strain (N=81). HI antibody responses fulfilled the European licensure criteria for immunogenicity (primary endpoint). The incidence of local and systemic solicited adverse events (reactogenicity) was higher with AS03-H5N1 than TIV. There was no apparent difference in the rate of unsolicited adverse events in the AS03-H5N1 and TIV groups.
  
  
  CONCLUSIONS
  The results indicate that AS03-H5N1 vaccine is immunogenic with reactogenicity and safety findings that are consistent with the established profile of AS03-H5N1 vaccine.
authors.affiliation: GSK Vaccines, Wavre, Belgium. Electronic address: patricia.s.izurieta@gsk.com.
authors.forename: Patricia
authors.initials: P
authors.lastname: Izurieta
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.
authors.forename: Woo Joo
authors.initials: WJ
authors.lastname: Kim
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, St. Vincent's Hospital, The Catholic University of Korea, Seoul, South Korea.
authors.forename: Seong-Heon
authors.initials: SH
authors.lastname: Wie
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea.
authors.forename: Jacob
authors.initials: J
authors.lastname: Lee
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea.
authors.forename: Jin-Soo
authors.initials: JS
authors.lastname: Lee
authors.affiliation: GSK Vaccines, King of Prussia, PA, USA.
authors.forename: Mamadou
authors.initials: M
authors.lastname: Dramé
authors.affiliation: GSK Vaccines, King of Prussia, PA, USA.
authors.forename: David W
authors.initials: DW
authors.lastname: Vaughn
authors.affiliation: GSK Vaccines, King of Prussia, PA, USA.
authors.forename: Anne
authors.initials: A
authors.lastname: Schuind
mesh_terms: D000276:Adjuvants, Immunologic; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood*; D000917:Antibody Formation / Q000276:immunology*; D004338:Drug Combinations; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007115:Immunization Schedule; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D058873:Pandemics / Q000517:prevention & control; D011136:Polysorbates; D056910:Republic of Korea; D013185:Squalene / Q000276:immunology*; D014611:Vaccination; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult; D024502:alpha-Tocopherol / Q000276:immunology*
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D004338:Drug Combinations; D007252:Influenza Vaccines; D011136:Polysorbates; D015164:Vaccines, Inactivated; D013185:Squalene; C550253:AS03 adjuvant; D024502:alpha-Tocopherol
keywords: AS03; H5N1 vaccine; Korean adults; Pandemic influenza