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Article: Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials

TitleEfficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials
Authors
Issue Date2007
PublisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lancet
Citation
Lancet, 2007, v. 369 n. 9574, p. 1693-1702 How to Cite?
AbstractBackground: Vulval and vaginal cancers among younger women are often related to infection with human papillomavirus (HPV). These cancers are preceded by high-grade vulval intraepithelial neoplasia (VIN2-3) and vaginal intraepithelial neoplasia (VaIN2-3). Our aim was to do a combined analysis of three randomised clinical trials to assess the effect of a prophylactic quadrivalent HPV vaccine on the incidence of these diseases. Methods: 18 174 women (16-26 years) were enrolled and randomised to receive either quadrivalent HPV6/11/16/18 L1 virus-like-particle vaccine or placebo at day 1, and months 2 and 6. Individuals underwent detailed anogenital examination at day 1, 1 month after dose three, and at 6-12-month intervals for up to 48 months. Suspect genital lesions were biopsied and read by a panel of pathologists and vaccine HPV type-specific DNA testing was done. The primary endpoint was the combined incidence of VIN2-3 or VaIN2-3 associated with HPV16 or HPV18. Primary efficacy analyses were done in a per-protocol population. Findings: The mean follow-up time was 3 years. Among women naive to HPV16 or HPV18 through 1 month after dose three (per-protocol population; vaccine n=7811; placebo n=7785), the vaccine was 100% effective (95% CI 72-100) against VIN2-3 or VaIN2-3 associated with HPV16 or HPV18. In the intention-to-treat population (which included 18 174 women who, at day 1, could have been infected with HPV16 or HPV18), vaccine efficacy against VIN2-3 or VaIN2-3 associated with HPV16 or HPV18 was 71% (37-88). The vaccine was 49% (18-69) effective against all VIN2-3 or VaIN2-3, irrespective of whether or not HPV DNA was detected in the lesion. The most common treatment-related adverse event was injection-site pain. Interpretation: Prophylactic administration of quadrivalent HPV vaccine was effective in preventing high-grade vulval and vaginal lesions associated with HPV16 or HPV18 infection in women who were naive to these types before vaccination. With time, such vaccination could result in reduced rates of HPV-related vulval and vaginal cancers. © 2007 Elsevier Ltd. All rights reserved.
Persistent Identifierhttp://hdl.handle.net/10722/173321
ISSN
2015 Impact Factor: 44.002
2015 SCImago Journal Rankings: 14.638
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorJoura, EAen_US
dc.contributor.authorLeodolter, Sen_US
dc.contributor.authorHernandezAvila, Men_US
dc.contributor.authorWheeler, CMen_US
dc.contributor.authorPerez, Gen_US
dc.contributor.authorKoutsky, LAen_US
dc.contributor.authorGarland, SMen_US
dc.contributor.authorHarper, DMen_US
dc.contributor.authorTang, GWen_US
dc.contributor.authorFerris, DGen_US
dc.contributor.authorSteben, Men_US
dc.contributor.authorJones, RWen_US
dc.contributor.authorBryan, Jen_US
dc.contributor.authorTaddeo, FJen_US
dc.contributor.authorBautista, OMen_US
dc.contributor.authorEsser, MTen_US
dc.contributor.authorSings, HLen_US
dc.contributor.authorNelson, Men_US
dc.contributor.authorBoslego, JWen_US
dc.contributor.authorSattler, Cen_US
dc.contributor.authorBarr, Een_US
dc.contributor.authorPaavonen, Jen_US
dc.date.accessioned2012-10-30T06:29:19Z-
dc.date.available2012-10-30T06:29:19Z-
dc.date.issued2007en_US
dc.identifier.citationLancet, 2007, v. 369 n. 9574, p. 1693-1702en_US
dc.identifier.issn0140-6736en_US
dc.identifier.urihttp://hdl.handle.net/10722/173321-
dc.description.abstractBackground: Vulval and vaginal cancers among younger women are often related to infection with human papillomavirus (HPV). These cancers are preceded by high-grade vulval intraepithelial neoplasia (VIN2-3) and vaginal intraepithelial neoplasia (VaIN2-3). Our aim was to do a combined analysis of three randomised clinical trials to assess the effect of a prophylactic quadrivalent HPV vaccine on the incidence of these diseases. Methods: 18 174 women (16-26 years) were enrolled and randomised to receive either quadrivalent HPV6/11/16/18 L1 virus-like-particle vaccine or placebo at day 1, and months 2 and 6. Individuals underwent detailed anogenital examination at day 1, 1 month after dose three, and at 6-12-month intervals for up to 48 months. Suspect genital lesions were biopsied and read by a panel of pathologists and vaccine HPV type-specific DNA testing was done. The primary endpoint was the combined incidence of VIN2-3 or VaIN2-3 associated with HPV16 or HPV18. Primary efficacy analyses were done in a per-protocol population. Findings: The mean follow-up time was 3 years. Among women naive to HPV16 or HPV18 through 1 month after dose three (per-protocol population; vaccine n=7811; placebo n=7785), the vaccine was 100% effective (95% CI 72-100) against VIN2-3 or VaIN2-3 associated with HPV16 or HPV18. In the intention-to-treat population (which included 18 174 women who, at day 1, could have been infected with HPV16 or HPV18), vaccine efficacy against VIN2-3 or VaIN2-3 associated with HPV16 or HPV18 was 71% (37-88). The vaccine was 49% (18-69) effective against all VIN2-3 or VaIN2-3, irrespective of whether or not HPV DNA was detected in the lesion. The most common treatment-related adverse event was injection-site pain. Interpretation: Prophylactic administration of quadrivalent HPV vaccine was effective in preventing high-grade vulval and vaginal lesions associated with HPV16 or HPV18 infection in women who were naive to these types before vaccination. With time, such vaccination could result in reduced rates of HPV-related vulval and vaginal cancers. © 2007 Elsevier Ltd. All rights reserved.en_US
dc.languageengen_US
dc.publisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lanceten_US
dc.relation.ispartofLanceten_US
dc.subject.meshAdolescenten_US
dc.subject.meshAdulten_US
dc.subject.meshCervical Intraepithelial Neoplasia - Prevention & Controlen_US
dc.subject.meshFemaleen_US
dc.subject.meshHumansen_US
dc.subject.meshMulticenter Studies As Topicen_US
dc.subject.meshPapillomaviridae - Immunologyen_US
dc.subject.meshPapillomavirus Infections - Prevention & Controlen_US
dc.subject.meshPapillomavirus Vaccinesen_US
dc.subject.meshRandomized Controlled Trials As Topicen_US
dc.subject.meshUterine Cervical Neoplasms - Prevention & Controlen_US
dc.titleEfficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trialsen_US
dc.typeArticleen_US
dc.identifier.emailTang, GW:gwktang@hkucc.hku.hken_US
dc.identifier.authorityTang, GW=rp00328en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1016/S0140-6736(07)60777-6en_US
dc.identifier.pmid17512854-
dc.identifier.scopuseid_2-s2.0-34249047002en_US
dc.identifier.hkuros127740-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-34249047002&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume369en_US
dc.identifier.issue9574en_US
dc.identifier.spage1693en_US
dc.identifier.epage1702en_US
dc.identifier.isiWOS:000246631300025-
dc.publisher.placeUnited Kingdomen_US
dc.identifier.scopusauthoridJoura, EA=7004817276en_US
dc.identifier.scopusauthoridLeodolter, S=7005056838en_US
dc.identifier.scopusauthoridHernandezAvila, M=7005968193en_US
dc.identifier.scopusauthoridWheeler, CM=7202505711en_US
dc.identifier.scopusauthoridPerez, G=16307983600en_US
dc.identifier.scopusauthoridKoutsky, LA=7006120337en_US
dc.identifier.scopusauthoridGarland, SM=7102220459en_US
dc.identifier.scopusauthoridHarper, DM=7202582929en_US
dc.identifier.scopusauthoridTang, GW=7401633864en_US
dc.identifier.scopusauthoridFerris, DG=17634377600en_US
dc.identifier.scopusauthoridSteben, M=6602790643en_US
dc.identifier.scopusauthoridJones, RW=9332922200en_US
dc.identifier.scopusauthoridBryan, J=7202481712en_US
dc.identifier.scopusauthoridTaddeo, FJ=6603004214en_US
dc.identifier.scopusauthoridBautista, OM=6602172290en_US
dc.identifier.scopusauthoridEsser, MT=7005625359en_US
dc.identifier.scopusauthoridSings, HL=8401383500en_US
dc.identifier.scopusauthoridNelson, M=16307807400en_US
dc.identifier.scopusauthoridBoslego, JW=6603879955en_US
dc.identifier.scopusauthoridSattler, C=16308028300en_US
dc.identifier.scopusauthoridBarr, E=7005643832en_US
dc.identifier.scopusauthoridPaavonen, J=7102724434en_US
dc.identifier.citeulike1320722-

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