Vaccination with a Human Papillomavirus (HPV)-16/18 AS04-Adjuvanted Cervical Cancer Vaccine in Korean Girls Aged 10-14 Years.
10.3346/jkms.2010.25.8.1197
- Author:
Young Jae KIM
1
;
Kyung Tai KIM
;
Jae Hoon KIM
;
Soon Do CHA
;
Jae Weon KIM
;
Duk Soo BAE
;
Joo Hyun NAM
;
Woong Shick AHN
;
Ho Sun CHOI
Author Information
1. Department of Obstetrics and Gynecology, College of Medicine, Hanyang University, Seoul, Korea. kimkt@hanyang.ac.kr
- Publication Type:Original Article ; Clinical Trial, Phase III ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
- Keywords:
Human papillomavirus;
HPV-16/18;
Uterine Cervical Neoplasms;
AS04-adjuvanted;
Prophylactic Vaccine;
VLP;
Immunogenicity;
Safety;
Adolescent
- MeSH:
Adjuvants, Immunologic/administration & dosage;
Adolescent;
Aluminum Hydroxide/administration & dosage;
Antibodies, Viral/analysis;
Child;
Female;
Hepatitis A/immunology;
Hepatitis A Vaccines/administration & dosage/adverse effects/immunology;
Humans;
Lipid A/administration & dosage/analogs & derivatives;
Papillomavirus Infections/*prevention & control;
Papillomavirus Vaccines/administration & dosage/adverse effects/*immunology;
Republic of Korea;
Seroepidemiologic Studies;
Uterine Cervical Neoplasms/*prevention & control
- From:Journal of Korean Medical Science
2010;25(8):1197-1204
- CountryRepublic of Korea
- Language:English
-
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.
