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Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions

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dc.creatorRuíz Sternberg, Ángela María
dc.date.accessioned2020-08-19T14:40:19Z
dc.date.available2020-08-19T14:40:19Z
dc.date.created2007-05-10spa
dc.description.abstractBACKGROUND Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18. METHODS In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18. RESULTS Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31). CONCLUSIONS In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group. (ClinicalTrials.gov number, NCT00092534. opens in new tab.)eng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.1056/NEJMoa061741
dc.identifier.issnISSN: 0028-4793
dc.identifier.issnEISSN: 1533-4406
dc.identifier.urihttps://repository.urosario.edu.co/handle/10336/26826
dc.language.isoengspa
dc.publisherMassachusetts Medical Societyspa
dc.relation.citationEndPage1927
dc.relation.citationIssueNo. 19
dc.relation.citationStartPage1915
dc.relation.citationTitleThe New England Journal of Medicine
dc.relation.citationVolumeVol. 356
dc.relation.ispartofThe New England Journal of Medicine, ISSN: 0028-4793;EISSN: 1533-4406, Vol.356, No.19 (2007); pp. 1915-1927spa
dc.relation.urihttps://www.nejm.org/doi/pdf/10.1056/NEJMoa061741?articleTools=truespa
dc.rights.accesRightsinfo:eu-repo/semantics/openAccess
dc.rights.accesoAbierto (Texto Completo)spa
dc.sourceThe New England Journal of Medicinespa
dc.source.instnameinstname:Universidad del Rosario
dc.source.reponamereponame:Repositorio Institucional EdocUR
dc.subject.keywordHematologyspa
dc.subject.keywordOncology gynecologicspa
dc.subject.keywordOncology dermatologyspa
dc.subject.keywordVaccines geneticsspa
dc.titleQuadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesionsspa
dc.title.TranslatedTitleVacuna cuadrivalente contra el virus del papiloma humano para prevenir lesiones cervicales de alto gradospa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
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