Published online 2011 Jun;22(2):67-75

Department of Obstetrics and Gynecology, ¹Ewha Womans University Mokdong Hospital, ²WCU Biomodulation in Major, Cancer Research Institute, Seoul National University Hospital, ³Severance Hospital, Yonsei University College of Medicine, ⁴Asan Medical Center, University of Ulsan College of Medicine, ⁵St. Mary's Hospital, The Catholic University of Korea School of Medicine, Seoul, Korea, ⁶GlaxoSmithKline Biologicals, Wavre, Belgium, ⁷Department of Obstetrics and Gynecology, Seoul St. Mary's Hospital, The Catholic University of Korea School of Medicine, Seoul, Korea

Objective: The study assessed the immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Korean women aged 15-25 years
Methods: Phase IIIB, double-blind, randomised (2:1), multi-centre trial was conducted in Korea from June 2007 to March 2008. The study enrolled 225 women in the HPV (N=149) and placebo (N=76) groups who received three doses of HPV-16/18 AS04-adju-vanted vaccine or placebo (aluminium hydroxide) administered intramuscularly at 0, 1, and 6 months and were followed until one month post-dose 3. Serum samples were collected pre-vaccination and one month post-dose 3. Safety and reactogenicity data were collected throughout.
Results: In this trial, 208 women completed the study (141 in HPV group; 67 in placebo group). At month 7, all initially seronega-tive women had seroconverted for HPV-16 and HPV-18 antibodies with anti-HPV-16 and anti-HPV-18 geometric mean titres of 9,351.4 El.U/mL (95% CI, 8,145.5 to 10,735.8) and 4204.1 El.U/mL (95% CI, 3,626.5 to 4,873.6), respectively. Initially seropositive women showed similar increase in geometric mean titre levels. Compliance to the three dose vaccination course was 95.3% in HPV and 89.5% in placebo group. Solicited local (pain) and general (fatigue, myalgia or headache) symptoms were commonly reported in both groups. Three serious adverse events were reported (two in HPV group; one in placebo group), all unrelated to vaccination by the investigator; all recovered.
Conclusion: The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic with a clinically acceptable safety profile in Korean women. This study was in line with previous global studies in Europe, North America, and Brazil. (ClinicalTrials.gov number, NCT 00485732.)

Keywords : AS04-adjuvanted, Cervical cancer, Geometric mean titres, Human papillomavirus-16/18, Immunogenicity, Sero con version