Article: Clinical trial experience with prophylactic HPV 6/11/16/18 VLP vaccine in young women from the Asia-Pacific region

File Download Links for fulltext
(May Require Subscription)
Supplementary

  • Basic View
  • Metadata View
  • XML View
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, G3
Nolan, T5
Huang, LM4
Orloski, L2
Lu, S2
Barr, E2
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
2011 Impact Factor: 2.045
2011 SCImago Journal Rankings: 0.130
DOIhttp://dx.doi.org/10.1016/j.ijgo.2008.03.021
ReferencesReferences in Scopus
DC Field
Value
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
2011 Impact Factor: 2.045
2011 SCImago Journal Rankings: 0.130
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
Author Affiliations
  1. KK Women's And Children's Hospital
  2. Merck Research Laboratories
  3. The University of Hong Kong
  4. National Taiwan University Hospital
  5. University of Melbourne