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J Gynecol Oncol. 2011 Jun;22(2):67-75. English. Randomized Controlled Trial. https://doi.org/10.3802/jgo.2011.22.2.67
Kim SC , Song YS , Kim YT , Kim YT , Ryu KS , Gunapalaiah B , Bi D , Bock HL , Park JS .
Department of Obstetrics and Gynecology, Ewha Womans University Mokdong Hospital, Seoul, Korea.
Department of Obstetrics and Gynecology, WCU Biomodulation in Major, Cancer Research Institute, Seoul National University Hospital, Seoul, Korea.
Department of Obstetrics and Gynecology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Department of Obstetrics and Gynecology, St. Mary's Hospital, The Catholic University of Korea School of Medicine, Seoul, Korea.
GlaxoSmithKline Biologicals, Wavre, Belgium.
Department of Obstetrics and Gynecology, Seoul St. Mary's Hospital, The Catholic University of Korea School of Medicine, Seoul, Korea. jspark@catholic.ac.kr
Abstract

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-adjuvanted 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 seronegative 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.)

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