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Article: Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases

TitleQuadrivalent vaccine against human papillomavirus to prevent anogenital diseases
Authors
Issue Date2007
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
Citation
New England Journal Of Medicine, 2007, v. 356 n. 19, p. 1928-1943 How to Cite?
AbstractBACKGROUND: A phase 3 trial was conducted to evaluate the efficacy of a prophylactic quadrivalent vaccine in preventing anogenital diseases associated with human papillomavirus (HPV) types 6, 11, 16, and 18. METHODS: In this randomized, placebo-controlled, double-blind trial involving 5455 women between the ages of 16 and 24 years, we assigned 2723 women to receive vaccine and 2732 to receive placebo at day 1, month 2, and month 6. The coprimary composite end points were the incidence of genital warts, vulvar or vaginal intraepithelial neoplasia, or cancer and the incidence of cervical intraepithelial neoplasia, adenocarcinoma in situ, or cancer associated with HPV type 6, 11, 16, or 18. Data for the primary analysis were collected for a per-protocol susceptible population of women who had no virologic evidence of HPV type 6, 11, 16, or 18 through 1 month after administration of the third dose. RESULTS: The women were followed for an average of 3 years after administration of the first dose. In the per-protocol population, those followed for vulvar, vaginal, or perianal disease included 2261 women (83%) in the vaccine group and 2279 (83%) in the placebo group. Those followed for cervical disease included 2241 women (82%) in the vaccine group and 2258 (83%) in the placebo group. Vaccine efficacy was 100% for each of the coprimary end points. In an intention-to-treat analysis, including those with prevalent infection or disease caused by vaccine-type and non-vaccine-type HPV, vaccination reduced the rate of any vulvar or vaginal perianal lesions regardless of the causal HPV type by 34% (95% confidence interval [CI], 15 to 49), and the rate of cervical lesions regardless of the causal HPV type by 20% (95% CI, 8 to 31). CONCLUSIONS: The quadrivalent vaccine significantly reduced the incidence of HPV-associated anogenital diseases in young women. Copyright © 2007 Massachusetts Medical Society.
Persistent Identifierhttp://hdl.handle.net/10722/87312
ISSN
2015 Impact Factor: 59.558
2015 SCImago Journal Rankings: 14.619
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorGarland, SMen_HK
dc.contributor.authorHernandezAvila, Men_HK
dc.contributor.authorWheeler, CMen_HK
dc.contributor.authorPerez, Gen_HK
dc.contributor.authorHarper, DMen_HK
dc.contributor.authorLeodolter, Sen_HK
dc.contributor.authorTang, GWKen_HK
dc.contributor.authorFerris, DGen_HK
dc.contributor.authorSteben, Men_HK
dc.contributor.authorBryan, Jen_HK
dc.contributor.authorTaddeo, FJen_HK
dc.contributor.authorRailkar, Ren_HK
dc.contributor.authorEsser, MTen_HK
dc.contributor.authorSings, HLen_HK
dc.contributor.authorNelson, Men_HK
dc.contributor.authorBoslego, Jen_HK
dc.contributor.authorSattler, Cen_HK
dc.contributor.authorBarr, Een_HK
dc.contributor.authorKoutsky, LAen_HK
dc.date.accessioned2010-09-06T09:28:03Z-
dc.date.available2010-09-06T09:28:03Z-
dc.date.issued2007en_HK
dc.identifier.citationNew England Journal Of Medicine, 2007, v. 356 n. 19, p. 1928-1943en_HK
dc.identifier.issn0028-4793en_HK
dc.identifier.urihttp://hdl.handle.net/10722/87312-
dc.description.abstractBACKGROUND: A phase 3 trial was conducted to evaluate the efficacy of a prophylactic quadrivalent vaccine in preventing anogenital diseases associated with human papillomavirus (HPV) types 6, 11, 16, and 18. METHODS: In this randomized, placebo-controlled, double-blind trial involving 5455 women between the ages of 16 and 24 years, we assigned 2723 women to receive vaccine and 2732 to receive placebo at day 1, month 2, and month 6. The coprimary composite end points were the incidence of genital warts, vulvar or vaginal intraepithelial neoplasia, or cancer and the incidence of cervical intraepithelial neoplasia, adenocarcinoma in situ, or cancer associated with HPV type 6, 11, 16, or 18. Data for the primary analysis were collected for a per-protocol susceptible population of women who had no virologic evidence of HPV type 6, 11, 16, or 18 through 1 month after administration of the third dose. RESULTS: The women were followed for an average of 3 years after administration of the first dose. In the per-protocol population, those followed for vulvar, vaginal, or perianal disease included 2261 women (83%) in the vaccine group and 2279 (83%) in the placebo group. Those followed for cervical disease included 2241 women (82%) in the vaccine group and 2258 (83%) in the placebo group. Vaccine efficacy was 100% for each of the coprimary end points. In an intention-to-treat analysis, including those with prevalent infection or disease caused by vaccine-type and non-vaccine-type HPV, vaccination reduced the rate of any vulvar or vaginal perianal lesions regardless of the causal HPV type by 34% (95% confidence interval [CI], 15 to 49), and the rate of cervical lesions regardless of the causal HPV type by 20% (95% CI, 8 to 31). CONCLUSIONS: The quadrivalent vaccine significantly reduced the incidence of HPV-associated anogenital diseases in young women. Copyright © 2007 Massachusetts Medical Society.en_HK
dc.languageengen_HK
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/en_HK
dc.relation.ispartofNew England Journal of Medicineen_HK
dc.rightsNew England Journal of Medicine. Copyright © Massachusetts Medical Society.en_HK
dc.titleQuadrivalent vaccine against human papillomavirus to prevent anogenital diseasesen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0028-4793&volume=356&issue=19&spage=1928&epage=1943&date=2007&atitle=Quadrivalent+vaccine+against+human+papillomavirus+to+prevent+anogenital+diseasesen_HK
dc.identifier.emailTang, GWK:gwktang@hkucc.hku.hken_HK
dc.identifier.authorityTang, GWK=rp00328en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1056/NEJMoa061760en_HK
dc.identifier.pmid17494926en_HK
dc.identifier.scopuseid_2-s2.0-34248365967en_HK
dc.identifier.hkuros131588en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-34248365967&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume356en_HK
dc.identifier.issue19en_HK
dc.identifier.spage1928en_HK
dc.identifier.epage1943en_HK
dc.identifier.isiWOS:000246305500005-
dc.publisher.placeUnited Statesen_HK
dc.identifier.f10001088787-
dc.identifier.scopusauthoridGarland, SM=7102220459en_HK
dc.identifier.scopusauthoridHernandezAvila, M=7005968193en_HK
dc.identifier.scopusauthoridWheeler, CM=7202505711en_HK
dc.identifier.scopusauthoridPerez, G=16307983600en_HK
dc.identifier.scopusauthoridHarper, DM=7202582929en_HK
dc.identifier.scopusauthoridLeodolter, S=7005056838en_HK
dc.identifier.scopusauthoridTang, GWK=7401633864en_HK
dc.identifier.scopusauthoridFerris, DG=17634377600en_HK
dc.identifier.scopusauthoridSteben, M=6602790643en_HK
dc.identifier.scopusauthoridBryan, J=7202481712en_HK
dc.identifier.scopusauthoridTaddeo, FJ=6603004214en_HK
dc.identifier.scopusauthoridRailkar, R=6507450848en_HK
dc.identifier.scopusauthoridEsser, MT=7005625359en_HK
dc.identifier.scopusauthoridSings, HL=8401383500en_HK
dc.identifier.scopusauthoridNelson, M=16307807400en_HK
dc.identifier.scopusauthoridBoslego, J=35983963400en_HK
dc.identifier.scopusauthoridSattler, C=16308028300en_HK
dc.identifier.scopusauthoridBarr, E=7005643832en_HK
dc.identifier.scopusauthoridKoutsky, LA=7006120337en_HK

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