Cited 21 times in
Human papillomavirus 16/18 AS04-adjuvanted cervical cancer vaccine: immunogenicity and safety in 15-25 years old healthy Korean women
DC Field | Value | Language |
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dc.contributor.author | 김영태 | - |
dc.date.accessioned | 2014-12-20T17:12:58Z | - |
dc.date.available | 2014-12-20T17:12:58Z | - |
dc.date.issued | 2011 | - |
dc.identifier.issn | 2005-0380 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/94176 | - |
dc.description.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.). | - |
dc.description.statementOfResponsibility | open | - |
dc.format.extent | 67~75 | - |
dc.relation.isPartOf | JOURNAL OF GYNECOLOGIC ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Antibodies | - |
dc.subject.MESH | Brazil | - |
dc.subject.MESH | Compliance | - |
dc.subject.MESH | Europe | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Human papillomavirus 16 | - |
dc.subject.MESH | Human papillomavirus 18 | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Korea | - |
dc.subject.MESH | North America | - |
dc.subject.MESH | Uterine Cervical Neoplasms | - |
dc.subject.MESH | Vaccination | - |
dc.title | Human papillomavirus 16/18 AS04-adjuvanted cervical cancer vaccine: immunogenicity and safety in 15-25 years old healthy Korean women | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Obstetrics & Gynecology (산부인과학) | - |
dc.contributor.googleauthor | Seung Cheol Kim | - |
dc.contributor.googleauthor | Yong Sang Song | - |
dc.contributor.googleauthor | Young-Tae Kim | - |
dc.contributor.googleauthor | Young Tak Kim | - |
dc.contributor.googleauthor | Ki-Sung Ryu | - |
dc.contributor.googleauthor | Bhavyashree Gunapalaiah | - |
dc.contributor.googleauthor | Dan Bi | - |
dc.contributor.googleauthor | Hans L Bock | - |
dc.contributor.googleauthor | Jong-Sup Park | - |
dc.identifier.doi | 10.3802/jgo.2011.22.2.67 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A00729 | - |
dc.relation.journalcode | J01428 | - |
dc.identifier.eissn | 2005-0399 | - |
dc.identifier.pmid | 21860731 | - |
dc.subject.keyword | AS04-adjuvanted | - |
dc.subject.keyword | Cervicalcancer | - |
dc.subject.keyword | Geometric mean titres | - |
dc.subject.keyword | Humanpapillomavirus-16/18 | - |
dc.subject.keyword | Immunogenicity | - |
dc.subject.keyword | Seroconversion | - |
dc.contributor.alternativeName | Kim, Young Tae | - |
dc.contributor.affiliatedAuthor | Kim, Young Tae | - |
dc.rights.accessRights | free | - |
dc.citation.volume | 22 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 67 | - |
dc.citation.endPage | 75 | - |
dc.identifier.bibliographicCitation | JOURNAL OF GYNECOLOGIC ONCOLOGY, Vol.22(2) : 67-75, 2011 | - |
dc.identifier.rimsid | 27290 | - |
dc.type.rims | ART | - |
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