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

• Published in: Journal of Korean medical science Vol. 25; no. 8; pp. 1197 - 1204
• Main Authors: Kim, Young-Jae, Kim, Kyung-Tai, Kim, Jae-Hoon, Cha, Soon-Do, Kim, Jae Weon, Bae, Duk-Soo, Nam, Joo-Hyun, Ahn, Woong-Shick, Choi, Ho-Sun
• Format: Journal Article
• Language: English
• Published: Korea (South) The Korean Academy of Medical Sciences 01.08.2010; 대한의학회
• Subjects: 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; Original; 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; 의학일반; Republic of Korea; Human papillomavirus; Uterine Cervical Neoplasms; Immunogenicity; AS04-adjuvanted; Adolescent; HPV-16/18; Prophylactic Vaccine; Safety; VLP
• ISSN: 1011-8934; 1598-6357; 1598-6357
• DOI: 10.3346/jkms.2010.25.8.1197

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.