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Vaccination with a Human Papillomavirus (HPV)-16/18 AS04-Adjuvanted Cervical Cancer Vaccine in Korean Girls Aged 10-14 Years.

Authors
 Young-Jae Kim  ;  Kyung-Tai Kim  ;  Jae-Hoon Kim  ;  Soon-Do Cha  ;  Jae Weon Kim  ;  Duk-Soo Bae  ;  Joo-Hyun Nam  ;  Woong-Shick Ahn  ;  Ho-Sun Choi 
Citation
 JOURNAL OF KOREAN MEDICAL SCIENCE, Vol.25(8) : 1197-1204, 2010 
Journal Title
 JOURNAL OF KOREAN MEDICAL SCIENCE 
ISSN
 1011-8934 
Issue Date
2010
MeSH
Adjuvants, Immunologic/administration & dosage ; Adolescent ; Aluminum Hydroxide/administration & dosage ; Antibodies, Viral/analysis ; Child ; Female ; Hepatitis A/immunology ; Hepatitis A Vaccines/administration & dosage ; Hepatitis A Vaccines/adverse effects ; Hepatitis A Vaccines/immunology ; Humans ; Lipid A/administration & dosage ; Lipid A/analogs & derivatives ; Papillomavirus Infections/prevention & control* ; Papillomavirus Vaccines/administration & dosage ; Papillomavirus Vaccines/adverse effects ; Papillomavirus Vaccines/immunology* ; Republic of Korea ; Seroepidemiologic Studies ; Uterine Cervical Neoplasms/prevention & control*
Keywords
AS04-adjuvanted ; Adolescent ; HPV-16/18 ; Human papillomavirus ; Immunogenicity ; Prophylactic Vaccine ; Safety ; Uterine Cervical Neoplasms ; VLP
Abstract
The human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine has been demonstrated to be highly efficacious and immunogenic with a favorable safety profile. This study assessed the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Korean girls aged 10-14 yr. This multi-center, observer-blind trial randomly assigned 321 healthy girls to receive three doses (0, 1, 6-month schedule) of HPV-16/18 AS04-adjuvanted vaccine or hepatitis A vaccine. Immunogenicity against vaccine antigens was assessed one month post-Dose 3. Solicited and unsolicited adverse events (AEs) and serious AEs (SAEs) were recorded. In the according-to-protocol analysis, all initially seronegative subjects vaccinated with the HPV-16/18 AS04-adjuvanted vaccine had seroconverted at Month 7, with a peak geometric mean titer (GMT) that was 600-fold higher than the natural infection titer of 29.8 EU/mL for HPV-16 and a peak GMT that was 400-fold higher than the natural infection titer of 22.6 EU/mL for HPV-18. The vaccine was well tolerated with no increase in reactogenicity with subsequent doses and no reports of vaccine-related SAEs. In conclusion, the HPV-16/18 AS04-adjuvanted vaccine is shown to be highly immunogenic and generally well-tolerated in Korean girls aged 10-14 yr
Files in This Item:
T201003221.pdf Download
DOI
10.3346/jkms.2010.25.8.1197
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Jae Hoon(김재훈) ORCID logo https://orcid.org/0000-0001-6599-7065
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/102044
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