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Article: Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: Randomised controlled trial

TitleFour year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: Randomised controlled trial
Authors
Issue Date2010
PublisherB M J Group. The Journal's web site is located at http://www.bmj.com/
Citation
Bmj (Online), 2010, v. 341 n. 7766, p. 239 How to Cite?
AbstractObjectives: To evaluate the prophylactic efficacy of the human papillomavirus (HPV) quadrivalent vaccine in preventing low grade cervical, vulvar, and vaginal intraepithelial neoplasias and anogenital warts (condyloma acuminata). Design: Data from two international, double blind, placebo controlled, randomised efficacy trials of quadrivalent HPV vaccine (protocol 013 (FUTURE I) and protocol 015 (FUTURE II)). The trials were to be 4 years in length, and the results reported are from final study data of 42 months' follow-up. Setting: Primary care centres and university or hospital associated health centres in 24 countries and territories around the world. Participants: 17 622 women aged 16-26 years enrolled between December 2001 and May 2003. Major exclusion criteria were lifetime number of sexual partners (>4), history of abnormal cervical smear test results, and pregnancy. Intervention: Three doses of quadrivalent HPV vaccine (for serotypes 6, 11, 16, and 18) or placebo at day 1, month 2, and month 6. Main outcome measures: Vaccine efficacy against cervical, vulvar, and vaginal intraepithelial neoplasia grade I and condyloma in a per protocol susceptible population that included subjects who received all three vaccine doses, tested negative for the relevant vaccine HPV types at day 1 and remained negative through month 7, and had no major protocol violations. Intention to treat, generally HPV naive, and unrestricted susceptible populations were also studied. Results: In the per protocol susceptible population, vaccine efficacy against lesions related to the HPV types in the vaccine was 96% for cervical intraepithelial neoplasia grade I (95% confidence interval 91% to 98%), 100% for both vulvar and vaginal intraepithelial neoplasia grade I (95% CIs 74% to 100%, 64% to 100% respectively), and 99% for condyloma (96% to 100%). Vaccine efficacy against any lesion (regardless of HPV type) in the generally naive population was 30% (17% to 41%), 75% (22% to 94%), and 48% (10% to 71%) for cervical, vulvar, and vaginal intraepithelial neoplasia grade I, respectively, and 83% (74% to 89%) for condyloma. Conclusions: Quadrivalent HPV vaccine provided sustained protection against low grade lesions attributable to vaccine HPV types (6, 11, 16, and 18) and a substantial reduction in the burden of these diseases through 42 months of follow-up. Trial registrations: NCT00092521 and NCT00092534.
Persistent Identifierhttp://hdl.handle.net/10722/123944
ISSN
2015 Impact Factor: 19.697
PubMed Central ID
ISI Accession Number ID
Funding AgencyGrant Number
Merck Research Laboratories, a division of Merck Company
Merck Company
Sanofi Pasteur MSD
Commonwealth Serum Laboratories
GlaxoSmithKline
Funding Information:

Merck Research Laboratories, a division of Merck & Company, funded these studies.

References

 

DC FieldValueLanguage
dc.contributor.authorDillner, Jen_HK
dc.contributor.authorKjaer, SKen_HK
dc.contributor.authorWheeler, CMen_HK
dc.contributor.authorSigurdsson, Ken_HK
dc.contributor.authorIversen, OEen_HK
dc.contributor.authorHernandezAvila, Men_HK
dc.contributor.authorPerez, Gen_HK
dc.contributor.authorBrown, DRen_HK
dc.contributor.authorKoutsky, LAen_HK
dc.contributor.authorTay, EHen_HK
dc.contributor.authorGarcía, Pen_HK
dc.contributor.authorAult, KAen_HK
dc.contributor.authorGarland, SMen_HK
dc.contributor.authorLeodolter, Sen_HK
dc.contributor.authorOlsson, SEen_HK
dc.contributor.authorTang, GWKen_HK
dc.contributor.authorFerris, DGen_HK
dc.contributor.authorPaavonen, Jen_HK
dc.contributor.authorLehtinen, Men_HK
dc.contributor.authorSteben, Men_HK
dc.contributor.authorBosch, FXen_HK
dc.contributor.authorJoura, EAen_HK
dc.contributor.authorMajewski, Sen_HK
dc.contributor.authorMuñoz, Nen_HK
dc.contributor.authorMyers, ERen_HK
dc.contributor.authorVilla, LLen_HK
dc.contributor.authorTaddeo, FJen_HK
dc.contributor.authorRoberts, Cen_HK
dc.contributor.authorTadesse, Aen_HK
dc.contributor.authorBryan, JTen_HK
dc.contributor.authorMaansson, Ren_HK
dc.contributor.authorLu, Sen_HK
dc.contributor.authorVuocolo, Sen_HK
dc.contributor.authorHesley, TMen_HK
dc.contributor.authorBarr, Een_HK
dc.contributor.authorHaupt, Ren_HK
dc.date.accessioned2010-10-12T02:22:33Z-
dc.date.available2010-10-12T02:22:33Z-
dc.date.issued2010en_HK
dc.identifier.citationBmj (Online), 2010, v. 341 n. 7766, p. 239en_HK
dc.identifier.issn1756-1833en_HK
dc.identifier.urihttp://hdl.handle.net/10722/123944-
dc.description.abstractObjectives: To evaluate the prophylactic efficacy of the human papillomavirus (HPV) quadrivalent vaccine in preventing low grade cervical, vulvar, and vaginal intraepithelial neoplasias and anogenital warts (condyloma acuminata). Design: Data from two international, double blind, placebo controlled, randomised efficacy trials of quadrivalent HPV vaccine (protocol 013 (FUTURE I) and protocol 015 (FUTURE II)). The trials were to be 4 years in length, and the results reported are from final study data of 42 months' follow-up. Setting: Primary care centres and university or hospital associated health centres in 24 countries and territories around the world. Participants: 17 622 women aged 16-26 years enrolled between December 2001 and May 2003. Major exclusion criteria were lifetime number of sexual partners (>4), history of abnormal cervical smear test results, and pregnancy. Intervention: Three doses of quadrivalent HPV vaccine (for serotypes 6, 11, 16, and 18) or placebo at day 1, month 2, and month 6. Main outcome measures: Vaccine efficacy against cervical, vulvar, and vaginal intraepithelial neoplasia grade I and condyloma in a per protocol susceptible population that included subjects who received all three vaccine doses, tested negative for the relevant vaccine HPV types at day 1 and remained negative through month 7, and had no major protocol violations. Intention to treat, generally HPV naive, and unrestricted susceptible populations were also studied. Results: In the per protocol susceptible population, vaccine efficacy against lesions related to the HPV types in the vaccine was 96% for cervical intraepithelial neoplasia grade I (95% confidence interval 91% to 98%), 100% for both vulvar and vaginal intraepithelial neoplasia grade I (95% CIs 74% to 100%, 64% to 100% respectively), and 99% for condyloma (96% to 100%). Vaccine efficacy against any lesion (regardless of HPV type) in the generally naive population was 30% (17% to 41%), 75% (22% to 94%), and 48% (10% to 71%) for cervical, vulvar, and vaginal intraepithelial neoplasia grade I, respectively, and 83% (74% to 89%) for condyloma. Conclusions: Quadrivalent HPV vaccine provided sustained protection against low grade lesions attributable to vaccine HPV types (6, 11, 16, and 18) and a substantial reduction in the burden of these diseases through 42 months of follow-up. Trial registrations: NCT00092521 and NCT00092534.en_HK
dc.languageeng-
dc.publisherB M J Group. The Journal's web site is located at http://www.bmj.com/-
dc.relation.ispartofBMJ (Online)en_HK
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.subject.meshCancer Vaccines-
dc.subject.meshCarcinoma in Situ - prevention and control-
dc.subject.meshCervical Intraepithelial Neoplasia - prevention and control-
dc.subject.meshPapillomavirus Infections - prevention and control-
dc.subject.meshPapillomavirus Vaccines-
dc.titleFour year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: Randomised controlled trialen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0959-535X&volume=341 article c3493&spage=&epage=&date=2010&atitle=Four+year+efficacy+of+prophylactic+human+papillomavirus+quadrivalent+vaccine+against+low-grade+cervical,+vulvar,+and+vaginal+intraepithelial+neoplasia+and+anogenital+warts:+randomised+controlled+trial-
dc.identifier.emailTang, GWK:gwktang@hkucc.hku.hken_HK
dc.identifier.authorityTang, GWK=rp00328en_HK
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1136/bmj.c3493en_HK
dc.identifier.pmid20647284-
dc.identifier.pmcidPMC2907480-
dc.identifier.scopuseid_2-s2.0-77955099933en_HK
dc.identifier.hkuros172215-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-77955099933&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume341en_HK
dc.identifier.issue7766en_HK
dc.identifier.spage239en_HK
dc.identifier.epage239en_HK
dc.identifier.isiWOS:000280411600005-
dc.identifier.scopusauthoridDillner, J=7007135194en_HK
dc.identifier.scopusauthoridKjaer, SK=7004418213en_HK
dc.identifier.scopusauthoridWheeler, CM=7202505711en_HK
dc.identifier.scopusauthoridSigurdsson, K=35475355400en_HK
dc.identifier.scopusauthoridIversen, OE=7102966661en_HK
dc.identifier.scopusauthoridHernandezAvila, M=7005968193en_HK
dc.identifier.scopusauthoridPerez, G=16307983600en_HK
dc.identifier.scopusauthoridBrown, DR=7407095050en_HK
dc.identifier.scopusauthoridKoutsky, LA=7006120337en_HK
dc.identifier.scopusauthoridTay, EH=7004902850en_HK
dc.identifier.scopusauthoridGarcía, P=7201693727en_HK
dc.identifier.scopusauthoridAult, KA=7005241226en_HK
dc.identifier.scopusauthoridGarland, SM=7102220459en_HK
dc.identifier.scopusauthoridLeodolter, S=7005056838en_HK
dc.identifier.scopusauthoridOlsson, SE=7202623557en_HK
dc.identifier.scopusauthoridTang, GWK=7401633864en_HK
dc.identifier.scopusauthoridFerris, DG=17634377600en_HK
dc.identifier.scopusauthoridPaavonen, J=7102724434en_HK
dc.identifier.scopusauthoridLehtinen, M=35479268300en_HK
dc.identifier.scopusauthoridSteben, M=6602790643en_HK
dc.identifier.scopusauthoridBosch, FX=7201833375en_HK
dc.identifier.scopusauthoridJoura, EA=7004817276en_HK
dc.identifier.scopusauthoridMajewski, S=7103224726en_HK
dc.identifier.scopusauthoridMuñoz, N=7102360543en_HK
dc.identifier.scopusauthoridMyers, ER=35433205900en_HK
dc.identifier.scopusauthoridVilla, LL=7102824355en_HK
dc.identifier.scopusauthoridTaddeo, FJ=6603004214en_HK
dc.identifier.scopusauthoridRoberts, C=35474924800en_HK
dc.identifier.scopusauthoridTadesse, A=6602812727en_HK
dc.identifier.scopusauthoridBryan, JT=7202481712en_HK
dc.identifier.scopusauthoridMaansson, R=35146242700en_HK
dc.identifier.scopusauthoridLu, S=54899768500en_HK
dc.identifier.scopusauthoridVuocolo, S=16403558200en_HK
dc.identifier.scopusauthoridHesley, TM=6603486789en_HK
dc.identifier.scopusauthoridBarr, E=7005643832en_HK
dc.identifier.scopusauthoridHaupt, R=11940557600en_HK

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