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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

TitleClinical trial experience with prophylactic HPV 6/11/16/18 VLP vaccine in young women from the Asia-Pacific region
Authors
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
Citation
International Journal Of Gynecology And Obstetrics, 2008, v. 102 n. 3, p. 275-283 How to Cite?
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.
Persistent Identifierhttp://hdl.handle.net/10722/87270
ISSN
2021 Impact Factor: 4.447
2020 SCImago Journal Rankings: 0.895
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorTay, EHen_HK
dc.contributor.authorGarland, Sen_HK
dc.contributor.authorTang, Gen_HK
dc.contributor.authorNolan, Ten_HK
dc.contributor.authorHuang, LMen_HK
dc.contributor.authorOrloski, Len_HK
dc.contributor.authorLu, Sen_HK
dc.contributor.authorBarr, Een_HK
dc.date.accessioned2010-09-06T09:27:31Z-
dc.date.available2010-09-06T09:27:31Z-
dc.date.issued2008en_HK
dc.identifier.citationInternational Journal Of Gynecology And Obstetrics, 2008, v. 102 n. 3, p. 275-283en_HK
dc.identifier.issn0020-7292en_HK
dc.identifier.urihttp://hdl.handle.net/10722/87270-
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.en_HK
dc.languageengen_HK
dc.publisherElsevier Ireland Ltd. The Journal's web site is located at http://www.elsevier.com/locate/ijgoen_HK
dc.relation.ispartofInternational Journal of Gynecology and Obstetricsen_HK
dc.rightsInternational Journal of Gynecology & Obstetrics. Copyright © Elsevier Ireland Ltd.en_HK
dc.subjectCervical canceren_HK
dc.subjectCervical intraepithelial neoplasiaen_HK
dc.subjectClinical trialen_HK
dc.subjectGenital wartsen_HK
dc.subjectHuman papillomavirusen_HK
dc.subjectProphylactic vaccineen_HK
dc.titleClinical trial experience with prophylactic HPV 6/11/16/18 VLP vaccine in young women from the Asia-Pacific regionen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://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+regionen_HK
dc.identifier.emailTang, G:gwktang@hkucc.hku.hken_HK
dc.identifier.authorityTang, G=rp00328en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1016/j.ijgo.2008.03.021en_HK
dc.identifier.pmid18555997en_HK
dc.identifier.scopuseid_2-s2.0-49349084203en_HK
dc.identifier.hkuros148483en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-49349084203&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume102en_HK
dc.identifier.issue3en_HK
dc.identifier.spage275en_HK
dc.identifier.epage283en_HK
dc.identifier.isiWOS:000259584400013-
dc.publisher.placeIrelanden_HK
dc.identifier.scopusauthoridTay, EH=7004902850en_HK
dc.identifier.scopusauthoridGarland, S=7102220459en_HK
dc.identifier.scopusauthoridTang, G=7401633864en_HK
dc.identifier.scopusauthoridNolan, T=7102073652en_HK
dc.identifier.scopusauthoridHuang, LM=7404736430en_HK
dc.identifier.scopusauthoridOrloski, L=6507316881en_HK
dc.identifier.scopusauthoridLu, S=54899768500en_HK
dc.identifier.scopusauthoridBarr, E=7005643832en_HK
dc.identifier.issnl0020-7292-

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