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- Publisher Website: 10.1016/j.ijgo.2008.03.021
- Scopus: eid_2-s2.0-49349084203
- PMID: 18555997
- WOS: WOS:000259584400013
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Article: Clinical trial experience with prophylactic HPV 6/11/16/18 VLP vaccine in young women from the Asia-Pacific region
Title | Clinical trial experience with prophylactic HPV 6/11/16/18 VLP vaccine in young women from the Asia-Pacific region |
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Authors | |
Keywords | Cervical cancer Cervical intraepithelial neoplasia Clinical trial Genital warts Human papillomavirus Prophylactic vaccine |
Issue Date | 2008 |
Publisher | Elsevier Ireland Ltd. The Journal's web site is located at http://www.elsevier.com/locate/ijgo |
Citation | International Journal Of Gynecology And Obstetrics, 2008, v. 102 n. 3, p. 275-283 How to Cite? |
Abstract | Objective: To evaluate results of three phase 3 clinical trials of quadrivalent HPV 6/11/16/18 vaccination of young Asia-Pacific women. Methods: A total of 814 women from the Asia-Pacific region (aged 16 to 26 years) received vaccine or placebo in 1 of 3 protocols. Descriptive analyses focused on the efficacy, safety, and immunogenicity of the vaccine and the natural history of HPV disease. Results: Vaccine efficacy against disease caused by HPV types 6, 11, 16, or 18 was 100% for cervical intraepithelial neoplasia (0 vs 12 cases; 95% confidence interval [CI], 63.1%-100%) and 100% for vulvar and vaginal intraepithelial neoplasia or condylomata accuminata (0 vs 5 cases; 95% CI, - 11.8% to 100%). The vaccination was highly immunogenic. Vaccine recipients experienced a significantly higher injection site adverse event rate (P = 0.002). Compared with other world regions, lower rates of smoking and baseline positivity to 14 HPV types (including the vaccine types) were observed among Asia-Pacific participants. Conclusion: Prophylactic quadrivalent HPV 6/11/16/18 vaccination of young Asia-Pacific women demonstrated high efficacy, safety, and tolerability. Together with an observed low baseline HPV positivity rate, the Asia-pacific population is potentially an important cohort to benefit from vaccination. © 2008 International Federation of Gynecology and Obstetrics. |
Persistent Identifier | http://hdl.handle.net/10722/87270 |
ISSN | 2023 Impact Factor: 2.6 2023 SCImago Journal Rankings: 0.951 |
ISI Accession Number ID | |
References |
DC Field | Value | Language |
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dc.contributor.author | Tay, EH | en_HK |
dc.contributor.author | Garland, S | en_HK |
dc.contributor.author | Tang, G | en_HK |
dc.contributor.author | Nolan, T | en_HK |
dc.contributor.author | Huang, LM | en_HK |
dc.contributor.author | Orloski, L | en_HK |
dc.contributor.author | Lu, S | en_HK |
dc.contributor.author | Barr, E | en_HK |
dc.date.accessioned | 2010-09-06T09:27:31Z | - |
dc.date.available | 2010-09-06T09:27:31Z | - |
dc.date.issued | 2008 | en_HK |
dc.identifier.citation | International Journal Of Gynecology And Obstetrics, 2008, v. 102 n. 3, p. 275-283 | en_HK |
dc.identifier.issn | 0020-7292 | en_HK |
dc.identifier.uri | http://hdl.handle.net/10722/87270 | - |
dc.description.abstract | Objective: To evaluate results of three phase 3 clinical trials of quadrivalent HPV 6/11/16/18 vaccination of young Asia-Pacific women. Methods: A total of 814 women from the Asia-Pacific region (aged 16 to 26 years) received vaccine or placebo in 1 of 3 protocols. Descriptive analyses focused on the efficacy, safety, and immunogenicity of the vaccine and the natural history of HPV disease. Results: Vaccine efficacy against disease caused by HPV types 6, 11, 16, or 18 was 100% for cervical intraepithelial neoplasia (0 vs 12 cases; 95% confidence interval [CI], 63.1%-100%) and 100% for vulvar and vaginal intraepithelial neoplasia or condylomata accuminata (0 vs 5 cases; 95% CI, - 11.8% to 100%). The vaccination was highly immunogenic. Vaccine recipients experienced a significantly higher injection site adverse event rate (P = 0.002). Compared with other world regions, lower rates of smoking and baseline positivity to 14 HPV types (including the vaccine types) were observed among Asia-Pacific participants. Conclusion: Prophylactic quadrivalent HPV 6/11/16/18 vaccination of young Asia-Pacific women demonstrated high efficacy, safety, and tolerability. Together with an observed low baseline HPV positivity rate, the Asia-pacific population is potentially an important cohort to benefit from vaccination. © 2008 International Federation of Gynecology and Obstetrics. | en_HK |
dc.language | eng | en_HK |
dc.publisher | Elsevier Ireland Ltd. The Journal's web site is located at http://www.elsevier.com/locate/ijgo | en_HK |
dc.relation.ispartof | International Journal of Gynecology and Obstetrics | en_HK |
dc.rights | International Journal of Gynecology & Obstetrics. Copyright © Elsevier Ireland Ltd. | en_HK |
dc.subject | Cervical cancer | en_HK |
dc.subject | Cervical intraepithelial neoplasia | en_HK |
dc.subject | Clinical trial | en_HK |
dc.subject | Genital warts | en_HK |
dc.subject | Human papillomavirus | en_HK |
dc.subject | Prophylactic vaccine | en_HK |
dc.title | Clinical trial experience with prophylactic HPV 6/11/16/18 VLP vaccine in young women from the Asia-Pacific region | en_HK |
dc.type | Article | en_HK |
dc.identifier.openurl | http://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0020-7292&volume=102 &issue=March&spage=275&epage=283&date=2008&atitle=Clinical+trial+experience+with+prophylactic+HPV+6/11/16/18+VLP+vaccine+in+young+women+from+the+Asia-Pacific+region | en_HK |
dc.identifier.email | Tang, G:gwktang@hkucc.hku.hk | en_HK |
dc.identifier.authority | Tang, G=rp00328 | en_HK |
dc.description.nature | link_to_subscribed_fulltext | - |
dc.identifier.doi | 10.1016/j.ijgo.2008.03.021 | en_HK |
dc.identifier.pmid | 18555997 | en_HK |
dc.identifier.scopus | eid_2-s2.0-49349084203 | en_HK |
dc.identifier.hkuros | 148483 | en_HK |
dc.relation.references | http://www.scopus.com/mlt/select.url?eid=2-s2.0-49349084203&selection=ref&src=s&origin=recordpage | en_HK |
dc.identifier.volume | 102 | en_HK |
dc.identifier.issue | 3 | en_HK |
dc.identifier.spage | 275 | en_HK |
dc.identifier.epage | 283 | en_HK |
dc.identifier.isi | WOS:000259584400013 | - |
dc.publisher.place | Ireland | en_HK |
dc.identifier.scopusauthorid | Tay, EH=7004902850 | en_HK |
dc.identifier.scopusauthorid | Garland, S=7102220459 | en_HK |
dc.identifier.scopusauthorid | Tang, G=7401633864 | en_HK |
dc.identifier.scopusauthorid | Nolan, T=7102073652 | en_HK |
dc.identifier.scopusauthorid | Huang, LM=7404736430 | en_HK |
dc.identifier.scopusauthorid | Orloski, L=6507316881 | en_HK |
dc.identifier.scopusauthorid | Lu, S=54899768500 | en_HK |
dc.identifier.scopusauthorid | Barr, E=7005643832 | en_HK |
dc.identifier.issnl | 0020-7292 | - |