Vaccination with a human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in Korean girls aged 10-14 years.
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.
Kim
Young-Jae
YJ
Department of Obstetrics and Gynecology, Hanyang University Hospital, [corrected] Seoul, Korea.
Kim
Kyung-Tai
KT
Kim
Jae-Hoon
JH
Cha
Soon-Do
SD
Kim
Jae Weon
JW
Bae
Duk-Soo
DS
Nam
Joo-Hyun
JH
Ahn
Woong-Shick
WS
Choi
Ho-Sun
HS
Ng
Timothy
T
Bi
Dan
D
OK
Jin-Ju
JJ
Descamps
Dominique
D
Bock
Hans L
HL
D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000536:Aluminum Hydroxide / Q000008:administration & dosage; D000914:Antibodies, Viral / Q000032:analysis; D002648:Child; D005260:Female; D006506:Hepatitis A / Q000276:immunology; D022362:Hepatitis A Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D008050:Lipid A / Q000008:administration & dosage / Q000031:analogs & derivatives; D030361:Papillomavirus Infections / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D056910:Republic of Korea; D016036:Seroepidemiologic Studies; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control*
C532963:ASO4 mixture; D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D022362:Hepatitis A Vaccines; D008050:Lipid A; D053918:Papillomavirus Vaccines; C510352:human papillomavirus vaccine, L1 type 16, 18; D000536:Aluminum Hydroxide