Vaccination with a Human Papillomavirus (HPV)-16/18 AS04-Adjuvanted Cervical Cancer Vaccine in Korean Girls Aged 10-14 Years
Journal of Korean Medical Science
; : 1197-1204, 2010.
Article
在 En
| WPRIM
| ID: wpr-187246
Responsible library:
WPRO
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.
Key words
全文:
1
索引:
WPRIM
主要主题:
Seroepidemiologic Studies
/
Uterine Cervical Neoplasms
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Adjuvants, Immunologic
/
Hepatitis A Vaccines
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Papillomavirus Infections
/
Papillomavirus Vaccines
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Aluminum Hydroxide
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Republic of Korea
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Hepatitis A
/
Lipid A
研究类型:
Clinical_trials
限制:
Adolescent
/
Child
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Female
/
Humans
国家/地区名称主题:
Asia
语言:
En
期刊:
Journal of Korean Medical Science
年:
2010
类型:
Article