Human papillomavirus 16/18 AS04-adjuvanted cervical cancer vaccine: Immunogenicity and safety in 15-25 years old healthy Korean women

Seung Cheol Kim, Yong Sang Song, Young Tae Kim, Young Tak Kim, Ki Sung Ryu, Bhavyashree Gunapalaiah, Dan Bi, Hans L. Bock, Jong Sup Park

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Objective: The study assessed the immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Korean women aged 15-25 years. Methods: Phase IIIB, double-blind, randomised (2:1), multi-centre trial was conducted in Korea from June 2007 to March 2008. The study enrolled 225 women in the HPV (N=149) and placebo (N=76) groups who received three doses of HPV-16/18 AS04-adjuvanted vaccine or placebo (aluminium hydroxide) administered intramuscularly at 0, 1, and 6 months and were followed until one month post-dose 3. Serum samples were collected pre-vaccination and one month post-dose 3. Safety and reactogenicity data were collected throughout. Results: In this trial, 208 women completed the study (141 in HPV group; 67 in placebo group). At month 7, all initially seronegative women had seroconverted for HPV-16 and HPV-18 antibodies with anti-HPV-16 and anti-HPV-18 geometric mean titres of 9,351.4 El.U/mL (95% CI, 8,145.5 to 10,735.8) and 4204.1 El.U/mL (95% CI, 3,626.5 to 4,873.6), respectively. Initially seropositive women showed similar increase in geometric mean titre levels. Compliance to the three dose vaccination course was 95.3% in HPV and 89.5% in placebo group. Solicited local (pain) and general (fatigue, myalgia or headache) symptoms were commonly reported in both groups. Three serious adverse events were reported (two in HPV group; one in placebo group), all unrelated to vaccination by the investigator; all recovered. Conclusion: The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic with a clinically acceptable safety profile in Korean women. This study was in line with previous global studies in Europe, North America, and Brazil. (ClinicalTrials.gov number, NCT 00485732.).

Original languageEnglish
Pages (from-to)67-75
Number of pages9
JournalJournal of Gynecologic Oncology
Volume22
Issue number2
DOIs
Publication statusPublished - 2011 Aug 29

Fingerprint

Human papillomavirus 18
Cancer Vaccines
Human papillomavirus 16
Uterine Cervical Neoplasms
Safety
Placebos
Vaccination
Vaccines
Aluminum Hydroxide
Myalgia
Korea
North America
Fatigue
Brazil
Headache
Vaccine Immunogenicity
Anti-Idiotypic Antibodies
Research Personnel
Pain
Serum

All Science Journal Classification (ASJC) codes

  • Oncology
  • Obstetrics and Gynaecology

Cite this

Kim, Seung Cheol ; Song, Yong Sang ; Kim, Young Tae ; Kim, Young Tak ; Ryu, Ki Sung ; Gunapalaiah, Bhavyashree ; Bi, Dan ; Bock, Hans L. ; Park, Jong Sup. / Human papillomavirus 16/18 AS04-adjuvanted cervical cancer vaccine : Immunogenicity and safety in 15-25 years old healthy Korean women. In: Journal of Gynecologic Oncology. 2011 ; Vol. 22, No. 2. pp. 67-75.
@article{8cdbb5a078e84e9a9e49a4cc5690d5ef,
title = "Human papillomavirus 16/18 AS04-adjuvanted cervical cancer vaccine: Immunogenicity and safety in 15-25 years old healthy Korean women",
abstract = "Objective: The study assessed the immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Korean women aged 15-25 years. Methods: Phase IIIB, double-blind, randomised (2:1), multi-centre trial was conducted in Korea from June 2007 to March 2008. The study enrolled 225 women in the HPV (N=149) and placebo (N=76) groups who received three doses of HPV-16/18 AS04-adjuvanted vaccine or placebo (aluminium hydroxide) administered intramuscularly at 0, 1, and 6 months and were followed until one month post-dose 3. Serum samples were collected pre-vaccination and one month post-dose 3. Safety and reactogenicity data were collected throughout. Results: In this trial, 208 women completed the study (141 in HPV group; 67 in placebo group). At month 7, all initially seronegative women had seroconverted for HPV-16 and HPV-18 antibodies with anti-HPV-16 and anti-HPV-18 geometric mean titres of 9,351.4 El.U/mL (95{\%} CI, 8,145.5 to 10,735.8) and 4204.1 El.U/mL (95{\%} CI, 3,626.5 to 4,873.6), respectively. Initially seropositive women showed similar increase in geometric mean titre levels. Compliance to the three dose vaccination course was 95.3{\%} in HPV and 89.5{\%} in placebo group. Solicited local (pain) and general (fatigue, myalgia or headache) symptoms were commonly reported in both groups. Three serious adverse events were reported (two in HPV group; one in placebo group), all unrelated to vaccination by the investigator; all recovered. Conclusion: The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic with a clinically acceptable safety profile in Korean women. This study was in line with previous global studies in Europe, North America, and Brazil. (ClinicalTrials.gov number, NCT 00485732.).",
author = "Kim, {Seung Cheol} and Song, {Yong Sang} and Kim, {Young Tae} and Kim, {Young Tak} and Ryu, {Ki Sung} and Bhavyashree Gunapalaiah and Dan Bi and Bock, {Hans L.} and Park, {Jong Sup}",
year = "2011",
month = "8",
day = "29",
doi = "10.3802/jgo.2011.22.2.67",
language = "English",
volume = "22",
pages = "67--75",
journal = "Journal of Gynecologic Oncology",
issn = "2005-0380",
publisher = "Korean Society of Gynecologic Oncology and Colposcopy",
number = "2",

}

Human papillomavirus 16/18 AS04-adjuvanted cervical cancer vaccine : Immunogenicity and safety in 15-25 years old healthy Korean women. / Kim, Seung Cheol; Song, Yong Sang; Kim, Young Tae; Kim, Young Tak; Ryu, Ki Sung; Gunapalaiah, Bhavyashree; Bi, Dan; Bock, Hans L.; Park, Jong Sup.

In: Journal of Gynecologic Oncology, Vol. 22, No. 2, 29.08.2011, p. 67-75.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Human papillomavirus 16/18 AS04-adjuvanted cervical cancer vaccine

T2 - Immunogenicity and safety in 15-25 years old healthy Korean women

AU - Kim, Seung Cheol

AU - Song, Yong Sang

AU - Kim, Young Tae

AU - Kim, Young Tak

AU - Ryu, Ki Sung

AU - Gunapalaiah, Bhavyashree

AU - Bi, Dan

AU - Bock, Hans L.

AU - Park, Jong Sup

PY - 2011/8/29

Y1 - 2011/8/29

N2 - Objective: The study assessed the immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Korean women aged 15-25 years. Methods: Phase IIIB, double-blind, randomised (2:1), multi-centre trial was conducted in Korea from June 2007 to March 2008. The study enrolled 225 women in the HPV (N=149) and placebo (N=76) groups who received three doses of HPV-16/18 AS04-adjuvanted vaccine or placebo (aluminium hydroxide) administered intramuscularly at 0, 1, and 6 months and were followed until one month post-dose 3. Serum samples were collected pre-vaccination and one month post-dose 3. Safety and reactogenicity data were collected throughout. Results: In this trial, 208 women completed the study (141 in HPV group; 67 in placebo group). At month 7, all initially seronegative women had seroconverted for HPV-16 and HPV-18 antibodies with anti-HPV-16 and anti-HPV-18 geometric mean titres of 9,351.4 El.U/mL (95% CI, 8,145.5 to 10,735.8) and 4204.1 El.U/mL (95% CI, 3,626.5 to 4,873.6), respectively. Initially seropositive women showed similar increase in geometric mean titre levels. Compliance to the three dose vaccination course was 95.3% in HPV and 89.5% in placebo group. Solicited local (pain) and general (fatigue, myalgia or headache) symptoms were commonly reported in both groups. Three serious adverse events were reported (two in HPV group; one in placebo group), all unrelated to vaccination by the investigator; all recovered. Conclusion: The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic with a clinically acceptable safety profile in Korean women. This study was in line with previous global studies in Europe, North America, and Brazil. (ClinicalTrials.gov number, NCT 00485732.).

AB - Objective: The study assessed the immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Korean women aged 15-25 years. Methods: Phase IIIB, double-blind, randomised (2:1), multi-centre trial was conducted in Korea from June 2007 to March 2008. The study enrolled 225 women in the HPV (N=149) and placebo (N=76) groups who received three doses of HPV-16/18 AS04-adjuvanted vaccine or placebo (aluminium hydroxide) administered intramuscularly at 0, 1, and 6 months and were followed until one month post-dose 3. Serum samples were collected pre-vaccination and one month post-dose 3. Safety and reactogenicity data were collected throughout. Results: In this trial, 208 women completed the study (141 in HPV group; 67 in placebo group). At month 7, all initially seronegative women had seroconverted for HPV-16 and HPV-18 antibodies with anti-HPV-16 and anti-HPV-18 geometric mean titres of 9,351.4 El.U/mL (95% CI, 8,145.5 to 10,735.8) and 4204.1 El.U/mL (95% CI, 3,626.5 to 4,873.6), respectively. Initially seropositive women showed similar increase in geometric mean titre levels. Compliance to the three dose vaccination course was 95.3% in HPV and 89.5% in placebo group. Solicited local (pain) and general (fatigue, myalgia or headache) symptoms were commonly reported in both groups. Three serious adverse events were reported (two in HPV group; one in placebo group), all unrelated to vaccination by the investigator; all recovered. Conclusion: The HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic with a clinically acceptable safety profile in Korean women. This study was in line with previous global studies in Europe, North America, and Brazil. (ClinicalTrials.gov number, NCT 00485732.).

UR - http://www.scopus.com/inward/record.url?scp=80051971653&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=80051971653&partnerID=8YFLogxK

U2 - 10.3802/jgo.2011.22.2.67

DO - 10.3802/jgo.2011.22.2.67

M3 - Article

C2 - 21860731

AN - SCOPUS:80051971653

VL - 22

SP - 67

EP - 75

JO - Journal of Gynecologic Oncology

JF - Journal of Gynecologic Oncology

SN - 2005-0380

IS - 2

ER -