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Clinical trial experience with prophylactic human papillomavirus 6/11/16/18 vaccine in young black women

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dc.creatorClark, Liana R.spa
dc.creatorMyers, Evan R.spa
dc.creatorHuh, Warnerspa
dc.creatorJoura, Elmar A.spa
dc.creatorPaavonen, Jormaspa
dc.creatorPerez, Gonzalospa
dc.creatorJames, Margaret K.spa
dc.creatorSings, Heather L.spa
dc.creatorHaupt, Richard M.spa
dc.creatorSaah, Alfred J.spa
dc.creatorGarner, Elizabeth I.O.spa
dc.date.accessioned2020-05-25T23:55:47Z
dc.date.available2020-05-25T23:55:47Z
dc.date.created2013spa
dc.description.abstractPurpose: Human papillomavirus (HPV) is the causative agent of cervical cancer. Black women are disproportionally diagnosed and have higher mortality from cervical cancer in the United States. Here we describe the prophylactic efficacy and safety of a quadrivalent HPV-6/11/16/18 vaccine in black women. Methods: A total of 700 black women from Latin America, Europe, and North America (aged 16-24 years) received the vaccine or placebo in one of two studies. Analyses focused on the efficacy and safety of the vaccine. Results: Baseline rates of Chlamydia trachomatis infection and history of past pregnancy were more than twice as high in black women compared with the non-black women who were enrolled in these trials. HPV-6/11/16 or 18 DNA was detected in 18% of black women versus 14.6% in non-black women at day 1. For black women, vaccine efficacy against disease caused by HPV-6/11/16/18 was 100% for cervical intraepithelial neoplasia (0 vs. 15 cases; 95% confidence interval, 64.5%-100%) and 100% for vulvar and vaginal intraepithelial neoplasia and condylomata acuminata (0 vs. 17 cases; 95% confidence interval, 69.3%-100%). There were no serious vaccine-related adverse experiences. A similar proportion of pregnancies resulted in live births (75.8% vaccine; 72.7% placebo) and fetal loss (24.2% vaccine; 27.3% placebo). Conclusions: Prophylactic quadrivalent HPV-6/11/16/18 vaccination of young black women demonstrated high efficacy, safety, and tolerability. HPV vaccination has the potential to reduce cervical cancer-related health disparities both in the United States and around the world. © 2013 Society for Adolescent Health and Medicine. All rights reserved.eng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.1016/j.jadohealth.2012.07.003
dc.identifier.issn1054139X
dc.identifier.urihttps://repository.urosario.edu.co/handle/10336/22218
dc.language.isoengspa
dc.relation.citationEndPage329
dc.relation.citationIssueNo. 3
dc.relation.citationStartPage322
dc.relation.citationTitleJournal of Adolescent Health
dc.relation.citationVolumeVol. 52
dc.relation.ispartofJournal of Adolescent Health, ISSN:1054139X, Vol.52, No.3 (2013); pp. 322-329spa
dc.relation.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-84874685177&doi=10.1016%2fj.jadohealth.2012.07.003&partnerID=40&md5=bcac6d519f64230879fcd416c7ad2b1espa
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.keywordWart virus vaccinespa
dc.subject.keywordAdultspa
dc.subject.keywordArticlespa
dc.subject.keywordChlamydiasisspa
dc.subject.keywordClinical trialspa
dc.subject.keywordCondyloma acuminatumspa
dc.subject.keywordDna virusspa
dc.subject.keywordDrug efficacyspa
dc.subject.keywordDrug safetyspa
dc.subject.keywordDrug withdrawalspa
dc.subject.keywordEthnicityspa
dc.subject.keywordFemalespa
dc.subject.keywordFetus deathspa
dc.subject.keywordFetus wastagespa
dc.subject.keywordHumanspa
dc.subject.keywordInfection preventionspa
dc.subject.keywordLive birthspa
dc.subject.keywordMajor clinical studyspa
dc.subject.keywordMedical historyspa
dc.subject.keywordPapillomavirus infectionspa
dc.subject.keywordPregnancy outcomespa
dc.subject.keywordPriority journalspa
dc.subject.keywordSide effectspa
dc.subject.keywordSpontaneous abortionspa
dc.subject.keywordUterine cervix carcinoma in situspa
dc.subject.keywordVaginal intraepithelial neoplasiaspa
dc.subject.keywordAdolescentspa
dc.subject.keywordAfrican americansspa
dc.subject.keywordAfrican continental ancestry groupspa
dc.subject.keywordAlphapapillomavirusspa
dc.subject.keywordChlamydia infectionsspa
dc.subject.keywordChlamydia trachomatisspa
dc.subject.keywordFemalespa
dc.subject.keywordHuman papillomavirus 11spa
dc.subject.keywordHumansspa
dc.subject.keywordPapillomaspa
dc.subject.keywordPapillomavirus infectionsspa
dc.subject.keywordPapillomavirus vaccinesspa
dc.subject.keywordUnited statesspa
dc.subject.keywordYoung adultspa
dc.subject.keywordCervical cancerspa
dc.subject.keywordHuman papillomavirusspa
dc.subject.keywordProphylactic efficacyspa
dc.subject.keywordVaccinespa
dc.titleClinical trial experience with prophylactic human papillomavirus 6/11/16/18 vaccine in young black womenspa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
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