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J Korean Med Sci. 2010 Aug;25(8):1197-204. doi: 10.3346/jkms.2010.25.8.1197. Epub 2010 Jul 21.

Vaccination with a human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in Korean girls aged 10-14 years.

Author information

1
Department of Obstetrics and Gynecology, Hanyang University Hospital, [corrected] Seoul, Korea.

Erratum in

  • J Korean Med Sci. 2010 Dec;25(12):1831. Ng, Timothy [added]; Bi, Dan [added]; OK, Jin-Ju [added]; Descamps, Dominique [added]; Bock, Hans L [added].

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.

KEYWORDS:

AS04-adjuvanted; Adolescent; HPV-16/18; Human papillomavirus; Immunogenicity; Prophylactic Vaccine; Safety; Uterine Cervical Neoplasms; VLP

PMID:
20676333
PMCID:
PMC2908791
DOI:
10.3346/jkms.2010.25.8.1197
[Indexed for MEDLINE]
Free PMC Article

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