PMID- 20676333
OWN - NLM
STAT- MEDLINE
DCOM- 20101124
LR  - 20220309
IS  - 1598-6357 (Electronic)
IS  - 1011-8934 (Print)
IS  - 1011-8934 (Linking)
VI  - 25
IP  - 8
DP  - 2010 Aug
TI  - Vaccination with a human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical 
      cancer vaccine in Korean girls aged 10-14 years.
PG  - 1197-204
LID - 10.3346/jkms.2010.25.8.1197 [doi]
AB  - 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.
FAU - Kim, Young-Jae
AU  - Kim YJ
AD  - Department of Obstetrics and Gynecology, Hanyang University Hospital, [corrected] 
      Seoul, Korea.
FAU - Kim, Kyung-Tai
AU  - Kim KT
FAU - Kim, Jae-Hoon
AU  - Kim JH
FAU - Cha, Soon-Do
AU  - Cha SD
FAU - Kim, Jae Weon
AU  - Kim JW
FAU - Bae, Duk-Soo
AU  - Bae DS
FAU - Nam, Joo-Hyun
AU  - Nam JH
FAU - Ahn, Woong-Shick
AU  - Ahn WS
FAU - Choi, Ho-Sun
AU  - Choi HS
FAU - Ng, Timothy
AU  - Ng T
FAU - Bi, Dan
AU  - Bi D
FAU - OK, Jin-Ju
AU  - OK JJ
FAU - Descamps, Dominique
AU  - Descamps D
FAU - Bock, Hans L
AU  - Bock HL
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100721
PL  - Korea (South)
TA  - J Korean Med Sci
JT  - Journal of Korean medical science
JID - 8703518
RN  - 0 (ASO4 mixture)
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Hepatitis A Vaccines)
RN  - 0 (Lipid A)
RN  - 0 (Papillomavirus Vaccines)
RN  - 0 (human papillomavirus vaccine, L1 type 16, 18)
RN  - 5QB0T2IUN0 (Aluminum Hydroxide)
SB  - IM
EIN - 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]
MH  - Adjuvants, Immunologic/administration & dosage
MH  - Adolescent
MH  - Aluminum Hydroxide/administration & dosage
MH  - Antibodies, Viral/analysis
MH  - Child
MH  - Female
MH  - Hepatitis A/immunology
MH  - Hepatitis A Vaccines/administration & dosage/adverse effects/immunology
MH  - Humans
MH  - Lipid A/administration & dosage/analogs & derivatives
MH  - Papillomavirus Infections/*prevention & control
MH  - Papillomavirus Vaccines/administration & dosage/adverse effects/*immunology
MH  - Republic of Korea
MH  - Seroepidemiologic Studies
MH  - Uterine Cervical Neoplasms/*prevention & control
PMC - PMC2908791
OTO - NOTNLM
OT  - AS04-adjuvanted
OT  - Adolescent
OT  - HPV-16/18
OT  - Human papillomavirus
OT  - Immunogenicity
OT  - Prophylactic Vaccine
OT  - Safety
OT  - Uterine Cervical Neoplasms
OT  - VLP
EDAT- 2010/08/03 06:00
MHDA- 2010/12/14 06:00
PMCR- 2010/08/01
CRDT- 2010/08/03 06:00
PHST- 2009/06/01 00:00 [received]
PHST- 2010/01/25 00:00 [accepted]
PHST- 2010/08/03 06:00 [entrez]
PHST- 2010/08/03 06:00 [pubmed]
PHST- 2010/12/14 06:00 [medline]
PHST- 2010/08/01 00:00 [pmc-release]
AID - 10.3346/jkms.2010.25.8.1197 [doi]
PST - ppublish
SO  - J Korean Med Sci. 2010 Aug;25(8):1197-204. doi: 10.3346/jkms.2010.25.8.1197. Epub 
      2010 Jul 21.