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Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women

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dc.creatorRuíz Sternberg, Ángela María
dc.creatorMoreira Jr, Edson D.
dc.creatorRestrepo, Jaime A.
dc.creatorLazcano-Ponce, Eduardo
dc.creatorCabello, Robinson
dc.creatorSilva, Arnaldo
dc.creatorAndrade, Rosires
dc.creatorRevollo, Francisco
dc.creatorUscanga, Santos
dc.creatorVictoria, Alejandro
dc.creatorGuevara, Ana María
dc.creatorLuna, Joaquín
dc.creatorPlata, Manuel
dc.creatorNossa Dominguez, Claudia
dc.creatorFedrizzi, Edison
dc.creatorSuarez, Eugenio
dc.creatorReina, Julio C.
dc.creatorEllison, Misoo C.
dc.creatorMoeller, Erin
dc.creatorRitter, Michael
dc.creatorShields, Christine
dc.creatorCashat, Miguel
dc.creatorPerez, Gonzalo
dc.creatorLuxembourg, Alain
dc.creator.googleRuiz-Sternberga, Ángela Maríaspa
dc.creator.googleMoreira Jr, Edson D.spa
dc.creator.googleRestrepo, Jaime A.spa
dc.creator.googleLazcano-Ponce, Eduardospa
dc.creator.googleCabello, Robinsonspa
dc.creator.googleSilva, Arnaldospa
dc.creator.googleAndrade, Rosiresspa
dc.creator.googleRevollo, Franciscospa
dc.creator.googleUscanga, Santosspa
dc.creator.googleVictoria, Alejandrospa
dc.creator.googleGuevara, Ana Maríaspa
dc.creator.googleLuna, Joaquínspa
dc.creator.googlePlata, Manuelspa
dc.creator.googleNossa Dominguez, Claudiaspa
dc.creator.googleFedrizzi, Edisonspa
dc.creator.googleSuarez, Eugeniospa
dc.creator.googleReina, Julio C.spa
dc.creator.googleEllison, Misoo C.spa
dc.creator.googleMoeller, Erinspa
dc.creator.googleRitter, Michaelspa
dc.creator.googleShields, Christinespa
dc.creator.googleCashat, Miguelspa
dc.creator.googlePerez, Gonzalospa
dc.creator.googleLuxembourg, Alainspa
dc.date.accessioned2018-11-29T21:28:53Z
dc.date.available2018-11-29T21:28:53Z
dc.date.created2018
dc.date.issued2018
dc.description.abstractBackground: A 9-valent human papillomavirus (HPV6/11/16/18/31/33/45/52/58; 9vHPV) vaccine was developed to expand coverage of the previously developed quadrivalent (HPV6/11/16/18; qHPV) vaccine. Methods: Efficacy, immunogenicity, and safety outcomes were assessed in Latin American participants enrolled in 2 international studies of the 9vHPV vaccine, including a randomized, double-blinded, controlled with qHPV vaccine, efficacy, immunogenicity, and safety study in young women aged 16–26 years, and an immunogenicity and safety study in girls and boys aged 9–15 years. Participants (N=5312) received vaccination at Day 1, Month 2, and Month 6. Gynecological swabs were collected regularly in young women for cytological and HPV DNA testing. Serum was analyzed for HPV antibodies in all participants. Adverse events (AEs) were also monitored in all participants. Results: The 9vHPV vaccine prevented HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical, vulvar, and vaginal dysplasia with 92.3% efficacy (95% confidence interval 54.4, 99.6). Anti-HPV6, 11, 16, and 18 geometric mean titers at Month 7 were similar in the 9vHPV and qHPV vaccination groups. Anti-HPV antibody responses following vaccination were higher among girls and boys than in young women. Most (>99%) 9vHPV vaccine recipients seroconverted for all 9 HPV types at Month 7. Antibody responses to the 9 HPV types persisted over 5 years. The most common AEs were injection-site related, mostly of mild to moderate intensity. Conclusions: The 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Latin American young women, girls, and boys. These data support 9vHPV vaccination programs in Latin America, a region with substantial cervical cancer burden. © 2018 Merck Sharp & Dohme Corp., and The Authorseng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.1016/j.pvr.2017.12.004
dc.identifier.issnISSN 2405-8521
dc.identifier.urihttp://repository.urosario.edu.co/handle/10336/18762
dc.language.isoengspa
dc.relation.citationEndPage74
dc.relation.citationStartPage63
dc.relation.citationTitlePapillomavirus Research
dc.relation.citationVolumeVol. 5
dc.relation.ispartofPapillomavirus Research, ISSN: 2405-8521, Vol. 5 (2018) pp. 63-74spa
dc.relation.urihttps://www.sciencedirect.com/science/article/pii/S2405852117300654spa
dc.rights.accesRightsinfo:eu-repo/semantics/openAccess
dc.rights.accesoAbierto (Texto Completo)spa
dc.rights.cchttps://creativecommons.org/licenses/by-nc-nd/4.0/spa
dc.source.bibliographicCitationInternational Agency for Research on Cancer, GLOBOCAN 2012: estimated cancer incidence (2012) Mortal. Preval. Worldw., , http://globocan.iarc.fr/Pages/fact_sheets_population.aspx, (accessed 12 June 2017)spa
dc.source.instnameinstname:Universidad del Rosario
dc.source.reponamereponame:Repositorio Institucional EdocUR
dc.subject9Vhpvspa
dc.subjectCervical Cancerspa
dc.subjectHuman Papillomavirusspa
dc.subjectPersistent Infectionspa
dc.subjectVaccinespa
dc.subject.decsVirus Antibodyspa
dc.subject.decsVirus Dnaspa
dc.subject.decsWart Virus Vaccinespa
dc.subject.decsAdolescentspa
dc.subject.decsAdultspa
dc.subject.decsAdverse Eventspa
dc.subject.decsAntibody Blood Levelspa
dc.subject.decsAntibody Responsespa
dc.subject.decsArticlespa
dc.subject.decsBlood Analysisspa
dc.subject.decsChildspa
dc.subject.decsControlled Studyspa
dc.subject.decsDisease Associationspa
dc.subject.decsDizzinessspa
dc.subject.decsDouble Blind Procedurespa
dc.subject.decsDrug Efficacyspa
dc.subject.decsDrug Fatalityspa
dc.subject.decsDrug Safetyspa
dc.subject.decsFemalespa
dc.subject.decsFeverspa
dc.subject.decsGynecological Examinationspa
dc.subject.decsHeadachespa
dc.subject.decsHispanicspa
dc.subject.decsHumanspa
dc.subject.decsHuman Papillomavirus Type 31spa
dc.subject.decsHuman Papillomavirus Type 33spa
dc.subject.decsHuman Papillomavirus Type 45spa
dc.subject.decsHuman Papillomavirus Type 52spa
dc.subject.decsHuman Papillomavirus Type 58spa
dc.subject.decsInjection Site Erythemaspa
dc.subject.decsInjection Site Painspa
dc.subject.decsInjection Site Pruritusspa
dc.subject.decsInjection Site Swellingspa
dc.subject.decsMajor Clinical Studyspa
dc.subject.decsMalespa
dc.subject.decsNauseaspa
dc.subject.decsPapillomavirus Infectionspa
dc.subject.decsPriority Journalspa
dc.subject.decsRandomized Controlled Trialspa
dc.subject.decsSeroconversionspa
dc.subject.decsTreatment Outcomespa
dc.subject.decsUterine Cervix Cytologyspa
dc.subject.decsUterine Cervix Dysplasiaspa
dc.subject.decsVaccinationspa
dc.subject.decsVaccine Immunogenicityspa
dc.subject.decsVagina Diseasespa
dc.subject.decsVagina Smearspa
dc.subject.decsVomitingspa
dc.subject.decsVulva Diseasespa
dc.subject.lembPapilomaspa
dc.subject.lembNeoplasias del cuello uterinospa
dc.subject.lembVacuna contra papilomavirusspa
dc.titleEfficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young womenspa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
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