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Evaluation of quadrivalent HPV 6/11/16/18 vaccine efficacy against cervical and anogenital disease in subjects with serological evidence of prior vaccine type HPV infection

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dc.creatorOlsson S.-E.spa
dc.creatorKjaer S.K.spa
dc.creatorSigurdsson K.spa
dc.creatorIversen O.-E.spa
dc.creatorHernandez-Avila M.spa
dc.creatorWheeler C.M.spa
dc.creatorPerez, Gonzalospa
dc.creatorBrown D.R.spa
dc.creatorKoutsky L.A.spa
dc.creatorTay E.H.spa
dc.creatorGarcía P.spa
dc.creatorAult K.A.spa
dc.creatorGarland S.M.spa
dc.creatorLeodolter S.spa
dc.creatorTang G.W.K.spa
dc.creatorFerris D.G.spa
dc.creatorPaavonen J.spa
dc.creatorLehtinen M.spa
dc.creatorSteben M.spa
dc.creatorBosch F.X.spa
dc.creatorDillner J.spa
dc.creatorJoura E.A.spa
dc.creatorMajewski S.spa
dc.creatorMuñoz N.spa
dc.creatorMyers E.R.spa
dc.creatorVilla L.L.spa
dc.creatorTaddeo F.J.spa
dc.creatorRoberts C.spa
dc.creatorTadesse A.spa
dc.creatorBryan J.spa
dc.creatorMaansson R.spa
dc.creatorVuocolo S.spa
dc.creatorHesley T.M.spa
dc.creatorSaah A.spa
dc.creatorBarr E.spa
dc.creatorHaupt R.M.spa
dc.date.accessioned2020-05-26T00:10:31Z
dc.date.available2020-05-26T00:10:31Z
dc.date.created2009spa
dc.description.abstractObjective: In the quadrivalent (types 6/11/16/18) HPV vaccine (GARDASIL®/SILGARD®) clinical program, 73% of women aged 16-26 were naïve to all vaccine HPV types. In these women, prophylactic administration of the vaccine was highly effective in preventing HPV 6/11/16/18-related cervical disease. Of the remaining women, 15% of had evidence of past infection with one or more vaccine HPV types (seropositive and DNA negative) at the time of enrollment. Here we present an analysis in this group of women to determine the efficacy of the HPV 6/11/16/18 vaccine against new cervical and external anogenital disease related to the same vaccine HPV type which had previously been cleared. Vaccine tolerability in this previously infected population was also assessed. Results: Subjects were followed for an average of 40 months. Seven subjects in the placebo group developed cervical disease, and eight subjects developed external genital disease related to a vaccine HPV type they had previously encountered. No subject receiving HPV 6/11/16/18 vaccine developed disease to a vaccine HPV type to which they were seropositive and DNA negative at enrollment. Methods: 18,174 women were enrolled into three clinical studies. The data presented comprise a subset of these subjects (n = 2,617) who were HPV seropositive and DNA negative at enrollment (for ?1 vaccine type). In each study, subjects were randomized in a 1:1 ratio to receive HPV 6/11/16/18 vaccine or placebo at day 1, month 2 and month 6 (without knowledge of baseline HPV status). Procedures performed for efficacy data evaluation included detailed genital examination, Pap testing and collection of cervicovaginal and external genital specimens. Analyses of efficacy were carried out in a population stratified by HPV serology and HPV DNA status at enrollment. Conclusions: These results suggest that natural HPV infection-elicited antibodies may not provide complete protection over time, however the immune response to the HPV 6/11/16/18 vaccine appears to prevent reinfection or reactivation of disease with vaccine HPV types. Vaccine-related adverse experiences were higher among subjects receiving vaccine, mostly due to increased injection site adverse experiences. © 2009 Landes Bioscience.eng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.4161/hv.5.10.9515
dc.identifier.urihttps://repository.urosario.edu.co/handle/10336/24233
dc.language.isoengspa
dc.relation.citationEndPage704
dc.relation.citationIssueNo. 10
dc.relation.citationStartPage696
dc.relation.citationTitleHuman Vaccines
dc.relation.citationVolumeVol. 5
dc.relation.ispartofHuman Vaccines, Vol.5, No.10 (2009); pp. 696-704spa
dc.relation.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-74049150705&doi=10.4161%2fhv.5.10.9515&partnerID=40&md5=f3d269bfa9855e5304b050970be39935spa
dc.rights.accesRightsinfo:eu-repo/semantics/openAccess
dc.rights.accesoAbierto (Texto Completo)spa
dc.source.instnameinstname:Universidad del Rosariospa
dc.source.reponamereponame:Repositorio Institucional EdocURspa
dc.subject.keywordPlacebospa
dc.subject.keywordviraleng
dc.subject.keywordSilgardspa
dc.subject.keywordUnclassified drugspa
dc.subject.keywordVirus dnaspa
dc.subject.keywordWart virus vaccinespa
dc.subject.keywordAdolescentspa
dc.subject.keywordAdultspa
dc.subject.keywordArticlespa
dc.subject.keywordBronchospasmspa
dc.subject.keywordControlled studyspa
dc.subject.keywordDrug efficacyspa
dc.subject.keywordDrug fatalityspa
dc.subject.keywordDrug tolerabilityspa
dc.subject.keywordDrug withdrawalspa
dc.subject.keywordFemalespa
dc.subject.keywordGastroenteritisspa
dc.subject.keywordGenital system examinationspa
dc.subject.keywordGynecologic diseasespa
dc.subject.keywordHeadachespa
dc.subject.keywordHumanspa
dc.subject.keywordHuman papillomavirus type 11spa
dc.subject.keywordHuman papillomavirus type 16spa
dc.subject.keywordHuman papillomavirus type 18spa
dc.subject.keywordHuman papillomavirus type 6spa
dc.subject.keywordHuman tissuespa
dc.subject.keywordHypertensionspa
dc.subject.keywordInjection site reactionspa
dc.subject.keywordMajor clinical studyspa
dc.subject.keywordPapanicolaou testspa
dc.subject.keywordProphylaxisspa
dc.subject.keywordSerologyspa
dc.subject.keywordUnspecified side effectspa
dc.subject.keywordUterine cervix diseasespa
dc.subject.keywordVerruca vulgarisspa
dc.subject.keywordAdolescentspa
dc.subject.keywordAdultspa
dc.subject.keywordAntibodieseng
dc.subject.keywordCervix uterispa
dc.subject.keywordFemalespa
dc.subject.keywordFollow-up studiesspa
dc.subject.keywordHumansspa
dc.subject.keywordPapillomavirus infectionsspa
dc.subject.keywordPapillomavirus vaccinesspa
dc.subject.keywordPlacebosspa
dc.subject.keywordVulvaspa
dc.subject.keywordYoung adultspa
dc.subject.keywordCervical cancerspa
dc.subject.keywordHpvspa
dc.subject.keywordVaccinespa
dc.titleEvaluation of quadrivalent HPV 6/11/16/18 vaccine efficacy against cervical and anogenital disease in subjects with serological evidence of prior vaccine type HPV infectionspa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
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