Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 김승철 | - |
dc.date.accessioned | 2016-08-28T12:08:55Z | - |
dc.date.available | 2016-08-28T12:08:55Z | - |
dc.date.issued | 2011 | - |
dc.identifier.issn | 2005-0380 | - |
dc.identifier.other | OAK-7751 | - |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/221763 | - |
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.). © 2011. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology and Colposcopy. | - |
dc.language | English | - |
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.relation.issue | 2 | - |
dc.relation.volume | 22 | - |
dc.relation.index | SCIE | - |
dc.relation.index | SCOPUS | - |
dc.relation.index | KCI | - |
dc.relation.startpage | 67 | - |
dc.relation.lastpage | 75 | - |
dc.relation.journaltitle | Journal of Gynecologic Oncology | - |
dc.identifier.doi | 10.3802/jgo.2011.22.2.67 | - |
dc.identifier.wosid | WOS:000292367200002 | - |
dc.identifier.scopusid | 2-s2.0-80051971653 | - |
dc.author.google | Kim S.C. | - |
dc.author.google | Song Y.S. | - |
dc.author.google | Kim Y.-T. | - |
dc.author.google | Kim Y.T. | - |
dc.author.google | Ryu K.-S. | - |
dc.author.google | Gunapalaiah B. | - |
dc.author.google | Bi D. | - |
dc.author.google | Bock H.L. | - |
dc.author.google | Park J.-S. | - |
dc.contributor.scopusid | 김승철(35264000100) | - |
dc.date.modifydate | 20230210135401 | - |