Vaccination with a Human Papillomavirus (HPV)-16/18 AS04-Adjuvanted Cervical Cancer Vaccine in Korean Girls Aged 10-14 Yearsopen access
- Authors
- Kim, YJ[Kim, Young-Jae]; Kim, KT[Kim, Kyung-Tai]; Kim, JH[Kim, Jae-Hoon]; Cha, SD[Cha, Soon-Do]; Kim, JW[Kim, Jae Weon]; Bae, DS[Bae, Duk-Soo]; Nam, JH[Nam, Joo-Hyun]; Ahn, WS[Ahn, Woong-Shick]; Choi, HS[Choi, Ho-Sun]
- Issue Date
- Aug-2010
- Publisher
- KOREAN ACAD MEDICAL SCIENCES
- Keywords
- Human papillomavirus; HPV-16/18; Uterine Cervical Neoplasms; AS04-adjuvanted; Prophylactic Vaccine; VLP; Immunogenicity; Safety; Adolescent
- Citation
- JOURNAL OF KOREAN MEDICAL SCIENCE, v.25, no.8, pp.1197 - 1204
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- JOURNAL OF KOREAN MEDICAL SCIENCE
- Volume
- 25
- Number
- 8
- Start Page
- 1197
- End Page
- 1204
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/73634
- DOI
- 10.3346/jkms.2010.25.8.1197
- ISSN
- 1011-8934
- 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 HPV16/18 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.
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Collections - Medicine > Department of Medicine > 1. Journal Articles
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