title: Immunogenicity and Safety of the AS04-adjuvanted Human Papillomavirus-16/18 Cervical Cancer Vaccine in Malaysian Women Aged 18-35 years: A Randomized Controlled Trial.
abstract: BACKGROUND
  Cervical cancer is the third most common cancer in women worldwide. The HPV-16/18 AS04- adjuvanted vaccine (Cervarix©) has previously been shown to be highly immunogenic with a clinically acceptable safety profile. This phase IIIb, double-blind, randomized (1:1) and placebo controlled trial (NCT00345878) was designed to evaluate the vaccine immunogenicity against HPV-16 and HPV-18 as well as its safety and reactogenicity in Malaysian women.
  
  
  METHODS
  Healthy women aged 18-35 years received intramuscularly three doses of either the vaccine (HPV group) or aluminium hydroxide (ALU group) at 0, 1, and 6 months. Antibody titers were measured by an enzyme-linked immunosorbent assay (ELISA).
  
  
  RESULTS
  A total of 271 eligible subjects were enrolled and 266 subjects completed the study. Initially seronegative subjects in the HPV group showed 100% seroconversion one month post-dose-3 for anti HPV-16 and anti-HPV-18 antibodies with geometric mean titers of 11107.5 (95% CI: 9727.3-12683.4) EL.U/mL and 4273.5 (95% CI: 3771.8-4841.9) EL.U/mL, respectively. Over 96% of subjects in both groups received all three vaccine doses. Solicited local (pain) and general symptoms (myalgia, fatigue, arthralgia and headache) were commonly reported in both HPV and ALU groups. Eight serious adverse events were reported throughout the study (five in the HPV group; three in the ALU group), all considered by investigators to be unrelated to vaccination.
  
  
  CONCLUSIONS
  The HPV-16/18 AS04-adjuvanted vaccine was immunogenic and generally well tolerated in Malaysian women aged 18-35 years.
authors.affiliation: University Malaya Medical Centre, Lembah Panta Kuala Lumpur, Malaysia. dan.x.bi@gsk.com.
authors.forename: B K
authors.initials: BK
authors.lastname: Lim
authors.affiliation: Putrajaya Hospital, Precint 7, Pusat Pentadbiran Kerajaan Persekutuan Putrajaya, Malaysia.
authors.forename: K Y
authors.initials: KY
authors.lastname: Ng
authors.affiliation: Putrajaya Hospital, Precint 7, Pusat Pentadbiran Kerajaan Persekutuan Putrajaya, Malaysia.
authors.forename: J
authors.initials: J
authors.lastname: Omar
authors.affiliation: University Malaya Medical Centre, Lembah Panta Kuala Lumpur, Malaysia.
authors.forename: S Z
authors.initials: SZ
authors.lastname: Omar
authors.affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium.
authors.forename: B
authors.initials: B
authors.lastname: Gunapalaiah
authors.affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium.
authors.forename: Y L
authors.initials: YL
authors.lastname: Teoh
authors.affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium.
authors.forename: H L
authors.initials: HL
authors.lastname: Bock
authors.affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium.
authors.forename: D
authors.initials: D
authors.lastname: Bi