title: Safety and immunogenicity of human papillomavirus-16/18 AS04-adjuvanted vaccine: a randomized trial in 10-25-year-old HIV-Seronegative African girls and young women.
abstract: BACKGROUND
  Cervical cancer is a major public health problem for women in sub-Saharan Africa. Availability of a human papillomavirus (HPV) vaccine could have an important public health impact.
  
  
  METHODS
  In this phase IIIb, double-blind, randomized, placebo-controlled, multicenter trial (NCT00481767), healthy African girls and young women seronegative for human immunodeficiency virus (HIV) were stratified by age (10-14 or 15-25 years) and randomized (2:1) to receive either HPV-16/18 AS04-adjuvanted vaccine (n = 450) or placebo (n = 226) at 0, 1, and 6 months. The primary objective was to evaluate HPV-16/18 antibody responses at month 7. Seropositivity rates and corresponding geometric mean titers (GMTs) were measured by enzyme-linked immunosorbent assay.
  
  
  RESULTS
  In the according-to-protocol analysis at month 7, 100% of initially seronegative participants in the vaccine group were seropositive for both anti-HPV-16 and anti-HPV-18 antibodies (n = 130 and n = 128 for 10-14-year-olds, respectively; n = 190 and n = 212 for 15-25-year-olds). GMTs for HPV-16 and HPV-18 were higher in 10-14-year-olds (18 423 [95% confidence interval, 16 185-20 970] and 6487 [5590-7529] enzyme-linked immunosorbent assay units (EU)/mL, respectively) than in 15-25-year-olds (10 683 [9567-11 930] and 3743 [3400-4120] EU/mL, respectively). Seropositivity was maintained at month 12. No participant withdrew owing to adverse events. No vaccine-related serious adverse events were reported.
  
  
  CONCLUSIONS
  The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic and had a clinically acceptable safety profile when administered to healthy HIV-seronegative African girls and young women.
authors.affiliation: CHU Fann, Service des Maladies Infectieuses, Dakar (Fann), Senegal.
authors.forename: Papa Salif
authors.initials: PS
authors.lastname: Sow
authors.forename: Deborah
authors.initials: D
authors.lastname: Watson-Jones
authors.forename: Nancy
authors.initials: N
authors.lastname: Kiviat
authors.forename: John
authors.initials: J
authors.lastname: Changalucha
authors.forename: Khardiata Diallo
authors.initials: KD
authors.lastname: Mbaye
authors.forename: Joelle
authors.initials: J
authors.lastname: Brown
authors.forename: Kouro
authors.initials: K
authors.lastname: Bousso
authors.forename: Bazil
authors.initials: B
authors.lastname: Kavishe
authors.forename: Aura
authors.initials: A
authors.lastname: Andreasen
authors.forename: Macoumba
authors.initials: M
authors.lastname: Toure
authors.forename: Saidi
authors.initials: S
authors.lastname: Kapiga
authors.forename: Philippe
authors.initials: P
authors.lastname: Mayaud
authors.forename: Richard
authors.initials: R
authors.lastname: Hayes
authors.forename: Marie
authors.initials: M
authors.lastname: Lebacq
authors.forename: Marjan
authors.initials: M
authors.lastname: Herazeh
authors.forename: Florence
authors.initials: F
authors.lastname: Thomas
authors.forename: Dominique
authors.initials: D
authors.lastname: Descamps
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D017954:Africa South of the Sahara; D000536:Aluminum Hydroxide / Q000008:administration & dosage* / Q000009:adverse effects; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D052162:Human papillomavirus 16 / Q000276:immunology*; D052161:Human papillomavirus 18 / Q000276:immunology*; D006801:Humans; D008050:Lipid A / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D030361:Papillomavirus Infections / Q000150:complications / Q000517:prevention & control* / Q000821:virology; D053918:Papillomavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D010919:Placebos / Q000008:administration & dosage; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control / Q000821:virology; D055815:Young Adult
chemical_list: C532963:ASO4 mixture; D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D008050:Lipid A; D053918:Papillomavirus Vaccines; D010919:Placebos; D000536:Aluminum Hydroxide