Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults.

dc.creatorMoreira Júnior, Edson Duarte
dc.creatorPalefsky, Joel M
dc.creatorGiuliano, Anna R
dc.creatorGoldstone, Stephen
dc.creatorAranda, Carlos
dc.creatorJessen, Heiko
dc.creatorHillman, Richard J
dc.creatorFerris, Daron G
dc.creatorCoutlee, Francois
dc.creatorVardas, Eftyhia
dc.creatorMarshall, J. Brooke
dc.creatorVuocolo, Scott
dc.creatorHaupt, Richard M
dc.creatorGuris, Dalya
dc.creatorGarner, Elizabeth I. O
dc.date2014-12-09T17:39:03Z
dc.date2014-12-09T17:39:03Z
dc.date2011
dc.date.accessioned2023-09-26T20:56:42Z
dc.date.available2023-09-26T20:56:42Z
dc.identifierMOREIRA JUNIOR, E. D. et al. Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults. Human Vaccines, v. 7, n. 7, p. 768-775, 2011.
dc.identifier1554-8619
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/9130
dc.identifierdx.doi.org/10.4161/hv.7.7.15579
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8866588
dc.descriptionBackground: Prophylactic vaccination with a quadrivalent HPV (types 6, 11, 16, 18) vaccine (qHPV) has been shown to prevent infection with HPV 6/11/16/18 and associated disease in women and more recently, in men. Here we report on the safety and reactogenicity of the qHPV vaccine in males. A total of 4,065 healthy males aged 16-26 years were enrolled into a randomized, placebo-controlled, double-blind trial. Subjects were randomized 1:1 to receive qHPV vaccine or placebo at day 1, month 2, and month 6. Safety and tolerability were assessed via the collection of reported adverse experiences (AEs). All serious AEs (vaccine- or procedure-related or not) and all deaths occurring during the study were recorded. Safety analyses were conducted in all subjects who received at least one dose of vaccine or placebo. The proportion of subjects who reported at least one injection-site AE was higher in the qHPV vaccine group versus the placebo group (60.1% vs 53.7%, respectively), however most of these AEs were mild/moderate in intensity. The incidence of at least one systemic AE was comparable between the vaccine and placebo groups (31.7% vs 31.4%, respectively). There were no vaccine-related serious AEs or deaths. The occurrence of AEs did not increase with each successive injection, and among trial participants who were seropositive for at least one vaccine HPV type at enrollment, the profile of adverse events was similar to that of the entire study cohort. The qHPV vaccine was generally well tolerated in males aged 16-26 years and had a favorable safety profile.
dc.formatapplication/pdf
dc.languageeng
dc.publisherTaylor & Francis
dc.rightsopen access
dc.subjectHuman papillomavirus (HPV)
dc.subjectVaccine
dc.subjectSafety
dc.subjectMale
dc.subjectAdult
dc.subjectAdolescent
dc.subjectVacinas contra Papillomavirus
dc.subjectVacinação/efeitos adversos
dc.subjectAdolescente
dc.subjectAdulto
dc.subjectMétodo Duplo-Cego
dc.subjectFeminino
dc.subjectPapillomavirus Humano 11/imunologia
dc.subjectPapillomavirus Humano 16/imunologia
dc.subjectHumanos
dc.subjectMasculino
dc.subjectInfecções por Papillomavirus/imunologia
dc.subjectInfecções por Papillomavirus/prevenção & controle
dc.subjectVacinas contra Papillomavirus/administração & dosagem
dc.subjectVacinas contra Papillomavirus/efeitos adversos
dc.subjectSegurança
dc.subjectAdulto Jovem
dc.titleSafety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults.
dc.typeArticle


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