Vaccination with a human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in Korean girls aged 10-14 years

Young Jae Kim, Kyung Tai Kim, Jae-Hoon Kim, Soon Do Cha, Jae Weon Kim, Duk Soo Bae, Joo Hyun Nam, Woong Shick Ahn, Ho Sun Choi

Research output: Contribution to journalArticle

25 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1197-1204
Number of pages8
JournalJournal of Korean medical science
Volume25
Issue number8
DOIs
Publication statusPublished - 2010 Aug 1

Fingerprint

Human papillomavirus 18
Cancer Vaccines
Human papillomavirus 16
Uterine Cervical Neoplasms
Vaccination
Vaccines
Hepatitis A Vaccines
Safety
Infection
Appointments and Schedules
Antigens

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

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. / Vaccination with a human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in Korean girls aged 10-14 years. In: Journal of Korean medical science. 2010 ; Vol. 25, No. 8. pp. 1197-1204.
@article{dc45210930084d479518f368eba5021c,
title = "Vaccination with a human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in Korean girls aged 10-14 years",
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.",
author = "Kim, {Young Jae} and Kim, {Kyung Tai} and Jae-Hoon Kim and Cha, {Soon Do} and Kim, {Jae Weon} and Bae, {Duk Soo} and Nam, {Joo Hyun} and Ahn, {Woong Shick} and Choi, {Ho Sun}",
year = "2010",
month = "8",
day = "1",
doi = "10.3346/jkms.2010.25.8.1197",
language = "English",
volume = "25",
pages = "1197--1204",
journal = "Journal of Korean Medical Science",
issn = "1011-8934",
publisher = "Korean Academy of Medical Science",
number = "8",

}

Vaccination with a human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in Korean girls aged 10-14 years. / 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.

In: Journal of Korean medical science, Vol. 25, No. 8, 01.08.2010, p. 1197-1204.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Vaccination with a human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in Korean girls aged 10-14 years

AU - Kim, Young Jae

AU - Kim, Kyung Tai

AU - Kim, Jae-Hoon

AU - Cha, Soon Do

AU - Kim, Jae Weon

AU - Bae, Duk Soo

AU - Nam, Joo Hyun

AU - Ahn, Woong Shick

AU - Choi, Ho Sun

PY - 2010/8/1

Y1 - 2010/8/1

N2 - 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.

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.

UR - http://www.scopus.com/inward/record.url?scp=77956587617&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77956587617&partnerID=8YFLogxK

U2 - 10.3346/jkms.2010.25.8.1197

DO - 10.3346/jkms.2010.25.8.1197

M3 - Article

VL - 25

SP - 1197

EP - 1204

JO - Journal of Korean Medical Science

JF - Journal of Korean Medical Science

SN - 1011-8934

IS - 8

ER -