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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
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TitleClinical trial experience with prophylactic HPV 6/11/16/18 VLP vaccine in young women from the Asia-Pacific region
 
AuthorsTay, EH1
Garland, S5
Tang, G2
Nolan, T5
Huang, LM4
Orloski, L3
Lu, S3
Barr, E3
 
KeywordsCervical cancer
Cervical intraepithelial neoplasia
Clinical trial
Genital warts
Human papillomavirus
Prophylactic vaccine
 
Issue Date2008
 
PublisherElsevier Ireland Ltd. The Journal's web site is located at http://www.elsevier.com/locate/ijgo
 
CitationInternational Journal Of Gynecology And Obstetrics, 2008, v. 102 n. 3, p. 275-283 [How to Cite?]
DOI: http://dx.doi.org/10.1016/j.ijgo.2008.03.021
 
AbstractObjective: 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.
 
ISSN0020-7292
2013 Impact Factor: 1.563
2013 SCImago Journal Rankings: 0.726
 
DOIhttp://dx.doi.org/10.1016/j.ijgo.2008.03.021
 
ISI Accession Number IDWOS:000259584400013
 
ReferencesReferences in Scopus
 
DC FieldValue
dc.contributor.authorTay, EH
 
dc.contributor.authorGarland, S
 
dc.contributor.authorTang, G
 
dc.contributor.authorNolan, T
 
dc.contributor.authorHuang, LM
 
dc.contributor.authorOrloski, L
 
dc.contributor.authorLu, S
 
dc.contributor.authorBarr, E
 
dc.date.accessioned2010-09-06T09:27:31Z
 
dc.date.available2010-09-06T09:27:31Z
 
dc.date.issued2008
 
dc.description.abstractObjective: 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.
 
dc.description.natureLink_to_subscribed_fulltext
 
dc.identifier.citationInternational Journal Of Gynecology And Obstetrics, 2008, v. 102 n. 3, p. 275-283 [How to Cite?]
DOI: http://dx.doi.org/10.1016/j.ijgo.2008.03.021
 
dc.identifier.doihttp://dx.doi.org/10.1016/j.ijgo.2008.03.021
 
dc.identifier.epage283
 
dc.identifier.hkuros148483
 
dc.identifier.isiWOS:000259584400013
 
dc.identifier.issn0020-7292
2013 Impact Factor: 1.563
2013 SCImago Journal Rankings: 0.726
 
dc.identifier.issue3
 
dc.identifier.openurl
 
dc.identifier.pmid18555997
 
dc.identifier.scopuseid_2-s2.0-49349084203
 
dc.identifier.spage275
 
dc.identifier.urihttp://hdl.handle.net/10722/87270
 
dc.identifier.volume102
 
dc.languageeng
 
dc.publisherElsevier Ireland Ltd. The Journal's web site is located at http://www.elsevier.com/locate/ijgo
 
dc.publisher.placeIreland
 
dc.relation.ispartofInternational Journal of Gynecology and Obstetrics
 
dc.relation.referencesReferences in Scopus
 
dc.rightsInternational Journal of Gynecology & Obstetrics. Copyright © Elsevier Ireland Ltd.
 
dc.subjectCervical cancer
 
dc.subjectCervical intraepithelial neoplasia
 
dc.subjectClinical trial
 
dc.subjectGenital warts
 
dc.subjectHuman papillomavirus
 
dc.subjectProphylactic vaccine
 
dc.titleClinical trial experience with prophylactic HPV 6/11/16/18 VLP vaccine in young women from the Asia-Pacific region
 
dc.typeArticle
 
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Author Affiliations
  1. KK Women's And Children's Hospital
  2. The University of Hong Kong
  3. Merck Research Laboratories
  4. National Taiwan University Hospital
  5. University of Melbourne