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Final efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16–26 years: a randomised, double-blind trial

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dc.creatorHuh, Warnerspa
dc.creatorJoura, Elmar A.spa
dc.creatorGiuliano, Anna Rspa
dc.creatorIversen, Ole-Erikspa
dc.creatorde Andrade, Rosires Pereiraspa
dc.creatorAult, Kevin Aspa
dc.creatorBartholomew, Deborahspa
dc.creatorCestero, Ramon Mspa
dc.creatorFedrizzi, Edison Nspa
dc.creatorHirschberg, Angelica Lspa
dc.creatorMayrand, Marie-Hélènespa
dc.creatorRuíz Sternberg, Ángela María
dc.creatorStapleton, Jack Tspa
dc.creatorWiley, Dorothy Jspa
dc.creatorFerenczy, Alexspa
dc.creatorKurman, Robertspa
dc.creatorRonnett, Brigitte Mspa
dc.creatorStoler, Mark Hspa
dc.creatorCuzick, Jackspa
dc.creatorGarland, Suzanne M.spa
dc.creatorKjaer, Susanne Kspa
dc.creatorBautista, Oliver Mspa
dc.creatorHaupt, Richardspa
dc.creatorMoeller, Erinspa
dc.creatorRitter, Michaelspa
dc.creatorRoberts, Christine Cspa
dc.creatorShields, Christinespa
dc.creatorLuxembourg, Alainspa
dc.date.accessioned2020-05-26T00:01:30Z
dc.date.available2020-05-26T00:01:30Z
dc.date.created2017spa
dc.description.abstractBackground Primary analyses of a study in young women aged 16–26 years showed efficacy of the nine-valent human papillomavirus (9vHPV; HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58) vaccine against infections and disease related to HPV 31, 33, 45, 52, and 58, and non-inferior HPV 6, 11, 16, and 18 antibody responses when compared with quadrivalent HPV (qHPV; HPV 6, 11, 16, and 18) vaccine. We aimed to report efficacy of the 9vHPV vaccine for up to 6 years following first administration and antibody responses over 5 years. Methods We undertook this randomised, double-blind, efficacy, immunogenicity, and safety study of the 9vHPV vaccine study at 105 study sites in 18 countries. Women aged 16–26 years old who were healthy, with no history of abnormal cervical cytology, no previous abnormal cervical biopsy results, and no more than four lifetime sexual partners were randomly assigned (1:1) by central randomisation and block sizes of 2 and 2 to receive three intramuscular injections over 6 months of 9vHPV or qHPV (control) vaccine. All participants, study investigators, and study site personnel, laboratory staff, members of the sponsor's study team, and members of the adjudication pathology panel were masked to vaccination groups. The primary outcomes were incidence of high-grade cervical disease (cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, invasive cervical carcinoma), vulvar disease (vulvar intraepithelial neoplasia grade 2/3, vulvar cancer), and vaginal disease (vaginal intraepithelial neoplasia grade 2/3, vaginal cancer) related to HPV 31, 33, 45, 52, and 58 and non-inferiority (excluding a decrease of 1·5 times) of anti-HPV 6, 11, 16, and 18 geometric mean titres (GMT). Tissue samples were adjudicated for histopathology diagnosis and tested for HPV DNA. Serum antibody responses were assessed by competitive Luminex immunoassay. The primary evaluation of efficacy was a superiority analysis in the per-protocol efficacy population, supportive efficacy was analysed in the modified intention-to-treat population, and the primary evaluation of immunogenicity was a non-inferiority analysis. The trial is registered with ClinicalTrials.gov, number NCT00543543. Findings Between Sept 26, 2007, and Dec 18, 2009, we recruited and randomly assigned 14 215 participants to receive 9vHPV (n=7106) or qHPV (n=7109) vaccine. In the per-protocol population, the incidence of high-grade cervical, vulvar and vaginal disease related to HPV 31, 33, 45, 52, and 58 was 0·5 cases per 10 000 person-years in the 9vHPV and 19·0 cases per 10 000 person-years in the qHPV groups, representing 97·4% efficacy (95% CI 85·0–99·9). HPV 6, 11, 16, and 18 GMTs were non-inferior in the 9vHPV versus qHPV group from month 1 to 3 years after vaccination. No clinically meaningful differences in serious adverse events were noted between the study groups. 11 participants died during the study follow-up period (six in the 9vHPV vaccine group and five in the qHPV vaccine group); none of the deaths were considered vaccine-related. Interpretation The 9vHPV vaccine prevents infection, cytological abnormalities, high-grade lesions, and cervical procedures related to HPV 31, 33, 45, 52, and 58. Both the 9vHPV vaccine and qHPV vaccine had a similar immunogenicity profile with respect to HPV 6, 11, 16, and 18. Vaccine efficacy was sustained for up to 6 years. The 9vHPV vaccine could potentially provide broader coverage and prevent 90% of cervical cancer cases worldwide. Funding Merck and Co, Inc. © 2017 Elsevier Ltdeng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.1016/S0140-6736(17)31821-4
dc.identifier.issn01406736
dc.identifier.issn1474547X
dc.identifier.urihttps://repository.urosario.edu.co/handle/10336/23374
dc.language.isoengspa
dc.publisherLancet Publishing Groupspa
dc.relation.citationEndPage2159
dc.relation.citationIssueNo. 10108
dc.relation.citationStartPage2143
dc.relation.citationTitleThe Lancet
dc.relation.citationVolumeVol. 390
dc.relation.ispartofThe Lancet, ISSN:01406736, 1474547X, Vol.390, No.10108 (2017); pp. 2143-2159spa
dc.relation.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85028880750&doi=10.1016%2fS0140-6736%2817%2931821-4&partnerID=40&md5=e0f4a6715450c6c51af30e8264c6b523spa
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.keywordVirus DNAspa
dc.subject.keywordDrugeng
dc.subject.keywordVirus antibodyspa
dc.subject.keywordWart virus vaccinespa
dc.subject.keywordAdenocarcinoma in situspa
dc.subject.keywordAdolescentspa
dc.subject.keywordAdultspa
dc.subject.keywordAnaphylaxisspa
dc.subject.keywordAntibody blood levelspa
dc.subject.keywordAntibody responsespa
dc.subject.keywordAntibody titerspa
dc.subject.keywordAppendicitisspa
dc.subject.keywordArticlespa
dc.subject.keywordCancer incidencespa
dc.subject.keywordCancer preventionspa
dc.subject.keywordControlled studyspa
dc.subject.keywordDouble blind procedurespa
dc.subject.keywordDrug efficacyspa
dc.subject.keywordDrug safetyspa
dc.subject.keywordFemalespa
dc.subject.keywordFetus wastagespa
dc.subject.keywordFollow upspa
dc.subject.keywordHumanspa
dc.subject.keywordHuman experimentspa
dc.subject.keywordHuman papillomavirus type 11spa
dc.subject.keywordHuman papillomavirus type 16spa
dc.subject.keywordHuman papillomavirus type 18spa
dc.subject.keywordHuman papillomavirus type 31spa
dc.subject.keywordHuman papillomavirus type 33spa
dc.subject.keywordHuman papillomavirus type 45spa
dc.subject.keywordHuman papillomavirus type 52spa
dc.subject.keywordHuman papillomavirus type 58spa
dc.subject.keywordHuman papillomavirus type 6spa
dc.subject.keywordHuman tissuespa
dc.subject.keywordImmunoassayspa
dc.subject.keywordIncidencespa
dc.subject.keywordInfection preventionspa
dc.subject.keywordIntention to treat analysisspa
dc.subject.keywordMulticenter studyspa
dc.subject.keywordNonhumanspa
dc.subject.keywordNormal humanspa
dc.subject.keywordOutcome assessmentspa
dc.subject.keywordPersistent virus infectionspa
dc.subject.keywordPriority journalspa
dc.subject.keywordRandomized controlled trialspa
dc.subject.keywordSeroconversionspa
dc.subject.keywordSide effectspa
dc.subject.keywordSpontaneous abortionspa
dc.subject.keywordUterine cervix carcinomaspa
dc.subject.keywordUterine cervix carcinoma in situspa
dc.subject.keywordUterine cervix cytologyspa
dc.subject.keywordVaccinationspa
dc.subject.keywordVaccine immunogenicityspa
dc.subject.keywordVaginal intraepithelial neoplasiaspa
dc.subject.keywordVulva cancerspa
dc.subject.keywordBloodspa
dc.subject.keywordClinical trialspa
dc.subject.keywordDose responsespa
dc.subject.keywordImmunologyspa
dc.subject.keywordIntramuscular drug administrationspa
dc.subject.keywordPapillomavirus infectionspa
dc.subject.keywordPatient compliancespa
dc.subject.keywordPatient safetyspa
dc.subject.keywordPrimary preventionspa
dc.subject.keywordProceduresspa
dc.subject.keywordStatistics and numerical dataspa
dc.subject.keywordTreatment outcomespa
dc.subject.keywordUterine cervix tumorspa
dc.subject.keywordVaccine immunogenicityspa
dc.subject.keywordVirologyspa
dc.subject.keywordYoung adultspa
dc.subject.keywordAdolescentspa
dc.subject.keywordAdultspa
dc.subject.keywordAntibodieseng
dc.subject.keywordDose-Response Relationshipeng
dc.subject.keywordDouble-Blind Methodspa
dc.subject.keywordFemalespa
dc.subject.keywordFollow-Up Studiesspa
dc.subject.keywordHuman papillomavirus 6spa
dc.subject.keywordHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18spa
dc.subject.keywordHumansspa
dc.subject.keywordImmunoassayspa
dc.subject.keywordImmunogenicityeng
dc.subject.keywordInjectionseng
dc.subject.keywordPapillomavirus Infectionsspa
dc.subject.keywordPatient Compliancespa
dc.subject.keywordPatient Safetyspa
dc.subject.keywordPrimary Preventionspa
dc.subject.keywordTreatment Outcomespa
dc.subject.keywordUterine Cervical Neoplasmsspa
dc.subject.keywordVaccinationspa
dc.subject.keywordYoung Adultspa
dc.titleFinal efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16–26 years: a randomised, double-blind trialspa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
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