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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 
 JOURNAL OF GYNECOLOGIC ONCOLOGY, Vol.22(2) : 67-75, 2011 
Journal Title
Issue Date
Aged ; Antibodies ; Brazil ; Compliance ; Europe ; Female ; Human papillomavirus 16 ; Human papillomavirus 18 ; Humans ; Korea ; North America ; Uterine Cervical Neoplasms ; Vaccination
AS04-adjuvanted ; Cervicalcancer ; Geometric mean titres ; Humanpapillomavirus-16/18 ; Immunogenicity ; Seroconversion
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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1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Young Tae(김영태) ORCID logo https://orcid.org/0000-0002-7347-1052
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