Human papillomavirus 16/18 AS04-adjuvanted cervical cancer vaccine: Immunogenicity and safety in 15-25 years old healthy Korean women

Seung Cheol Kim, Yong Sang Song, Young Tae Kim, Young Tak Kim, Ki Sung Ryu, Bhavyashree Gunapalaiah, Dan Bi, Hans L. Bock, Jong Sup Park

Research output: Contribution to journalArticle

13 Citations (Scopus)

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.).

Original languageEnglish
Pages (from-to)67-75
Number of pages9
JournalJournal of Gynecologic Oncology
Volume22
Issue number2
DOIs
Publication statusPublished - 2011 Aug 29

All Science Journal Classification (ASJC) codes

  • Oncology
  • Obstetrics and Gynaecology

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