title: Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine: a randomized, controlled trial in adolescent girls.
abstract: OBJECTIVE
  Immunization of girls against oncogenic human papillomavirus (HPV) types before sexual debut is important for cervical cancer prevention. This phase III blinded, randomized, controlled trial in adolescent girls assessed safety of the HPV-16/18 AS04-adjuvanted vaccine.
  
  
  METHODS
  Girls (mean age 12 years) in 12 countries received the HPV-16/18 L1 virus-like particle AS04-adjuvanted vaccine (N = 1,035) or hepatitis A virus vaccine as control (N = 1,032) at 0, 1, and 6 months. The primary objective was to compare the occurrence of serious adverse events (SAEs) between groups. HPV-16 and HPV-18 antibody titers were assessed by enzyme-linked immunosorbent assay post-vaccination.
  
  
  RESULTS
  Up to study month 7, 11 girls in the HPV-16/18 vaccine group reported 14 SAEs and 13 girls in the control group reported 15 SAEs. The difference in SAE incidence between groups was .20% (95% CI, -.78, 1.20). No SAE in the HPV-16/18 vaccine group was considered related to vaccination or led to withdrawal. The incidence of solicited local and general symptoms up to 7 days post-vaccination was moderately higher with the HPV-16/18 vaccine than with control. The incidence of unsolicited symptoms, new onset of chronic diseases, and medically significant conditions was similar between groups. All girls seroconverted for both antigens after three doses of the HPV-16/18 vaccine; geometric mean titers were 19,882.0 and 8,262.0 EU/mL for anti-HPV-16 and -18 antibodies, respectively, in initially seronegative girls.
  
  
  CONCLUSIONS
  The HPV-16/18 AS04-adjuvanted vaccine was generally well tolerated and immunogenic when administered to young adolescent females, the primary target of organized vaccination programs.
authors.affiliation: Organización para el Desarrollo y la Investigación Salud en Honduras, Tegucigalpa, Honduras. mriveram2002@yahoo.com.mx
authors.forename: Doris M Rivera
authors.initials: DM
authors.lastname: Medina
authors.forename: Alejandra
authors.initials: A
authors.lastname: Valencia
authors.forename: Alet
authors.initials: A
authors.lastname: de Velasquez
authors.forename: Li-Min
authors.initials: LM
authors.lastname: Huang
authors.forename: Roman
authors.initials: R
authors.lastname: Prymula
authors.forename: Jose
authors.initials: J
authors.lastname: García-Sicilia
authors.forename: Lars
authors.initials: L
authors.lastname: Rombo
authors.forename: Marie Pierre P
authors.initials: MP
authors.lastname: David
authors.forename: Dominique
authors.initials: D
authors.lastname: Descamps
authors.forename: Karin
authors.initials: K
authors.lastname: Hardt
authors.forename: Gary
authors.initials: G
authors.lastname: Dubin
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D005060:Europe; D005260:Female; D052162:Human papillomavirus 16 / Q000276:immunology*; D052161:Human papillomavirus 18 / Q000276:immunology*; D006801:Humans; D030361:Papillomavirus Infections / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D053918:Papillomavirus Vaccines